42 Empregos para Usp - Brasil

Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies, and the research, review and reporting on applicable global regulations and requirements. Develop stakeholder tools, process/document regulatory risk assessments, and provide support, expertise and represent the unit with other functional units, sponsors, researchers and/or regulatory authorities. Ensure high quality, timely service delivery processes are maintained in accordance with corporate, industry and regulatory standards and guidelines. May be required to coach peers and/or provide input for staff performance reviews.

Unit Management

• Coordinate the day to day delivery of regulatory services and processes, including compilation of regulatory filings/submissions/revisions for projects, third party vendors and clinical sites.
• Conduct or assist with regulatory and/or safety reviews, create regulatory-related tools, educational/training materials, and remain current on all aspects of clinical research regulatory requirements and industry best practices, communicating changes to project leaders in a timely manner.

Client Services

• As the corporate subject specialist in regulatory affairs, provide regulatory, ethics and/or pharmacovigilance guidance and support to project stakeholders.
• Represent the unit at project meetings, assisting with project education/regulatory tool development, at regulatory reviews and audits, with clients ensuring expectations are managed and met, with regulatory, ethics and government representatives and, when appropriate, respond to regulatory queries on behalf of the client.

Regulatory Strategy Development

• Identify changes in clinical research regulatory requirements and industry best practices and recommend, implement, and maintain corporate regulatory strategies, working with other experts (safety, quality assurance) when appropriate, to meet or exceed compliance requirements of evolving regulatory initiatives.
• Participate in specialized conferences/meetings to increase knowledge as needed.

Project Support

• Regularly respond to registration requests and work with project teams to identify regulatory requirements.
• Assist in the preparation of regulatory submissions and support summaries.
• Ensure project/clinical site files and documents are developed, maintained, revised, archived and/or destroyed in accordance with project and regulatory requirements and that all project stakeholders are fully informed and trained on all applicable regulatory requirements.

Qualifications

• Applicants should have a minimum of an undergraduate degree and 4-6 years of relevant experience in Clinical Research/Regulatory Affairs.
• The successful candidate will possess strong knowledge of LATAM clinical trial regulations.
• Fluency in English and Spanish (written and verbal) required.

Working Conditions

• Home-based
• *Accommodations for job applicants with disabilities are available upon request.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Kenvue is currently recruiting for a:

Regulatory Affairs Assistant

What we do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON'S and BAND-AID that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you Join us in shaping our future–and yours.

Role reports to:

GER ASSUN REGUL

Location:

Latin America, Brazil, Sao Paulo, Sao Jose dos Campos

Work Location:

Hybrid

What you will do

Kenvue is currently recruiting for:

This position reports into Regulatory Affairs Manager and is based at Sao Paulo, Brazil or Sao Jose dos Campos, Brazil.

Who we are

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON'S and BAND-AID that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you Join us in shaping our future–and yours.

Role reports to: Regulatory Affairs Manager

Location: Sao Paulo, Brazil or Sao Jose dos Campos, Brazil

What you will do

The successful candidate will have the unique opportunity to work closely with our whole regulatory team as a liaison and lead important projects. This is a rare chance to immerse yourself in the entire Regulatory Affairs (RA) landscape and collaborate on groundbreaking projects. You will oversee the Essential Health franchise across LATAM, managing beloved brands like Johnson's Baby, Listerine, Sempre Livre, and more. In this highly strategic role, you will connect with local RA teams across regions and work with a multifaceted group of professionals from Marketing, R&D, Supply Chain, Quality Assurance, and others to drive and implement regulatory strategies.

Additionally, they provide general administrative support as directed:

Key Responsibilities

• Collaborate Across Functions: Serve as a vital link, offering support to both local and regional RA teams.
• Ensure Business Continuity: Execute robust regulatory strategies to maintain seamless operations.
• Communicate Effectively: Identify local/regional regulatory submission requirements.
• Documentation and Dossier Preparation: Aid in the review of technical documents and the compilation of regulatory dossiers.
• Strategic Discussions: Participate in project team meetings with RA leads, contributing to high-level strategic discussions.
• Compliance Assurance: Review and approve artwork and labels to ensure regulatory compliance.
• Status Updates: Present regular updates on regulatory and project activities to key internal stakeholders.
• Regulatory Partnership: Collaborate with RA Liaisons and local RA colleagues to achieve regulatory success.

What we are looking for

Required Qualifications

• Bachelor's degree in progress by Q4'2026
• Intermediate English
• Strong attention to detail and organizational skills
• Excellent written and verbal communication skills
• Proficiency in Microsoft Office and database management
• Some knowledge in Cosmetics or Pharma regulations, guidelines, policies, etc. and Health Authorities in LATAM.
• Strong connection and teamwork skill with ability to work and communication with different partners like Marketing, Local Regulatory, Supply Chain and Quality.

Note: Potential internal candidates may have been identified for this position based on existing succession and/or development plans. However, all candidates are required to formally apply to the process.

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.

Regulatory Affairs Specialist Post Register - Home based - São Paulo

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Regulatory Affairs Specialist to join our diverse and dynamic team. As a Regulatory Affairs Specialist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of inNvative treatments and therapies.

What you will be doing

• Undertaking variable duties based on project requirements, primarily within Pharmaceutical, BiotechNlogy, or Biologics Regulatory Affairs, with potential involvement in related areas.

• Contributing to regulatory submissions team activities, including preparation, compilation, and submission of regulatory documents such as CT/IND, MAA/NA, variations/lifecycle submissions, DSUR, PSUR, renewals, and agency briefing documentation.

• Managing and implementing label review, translation requirements, fee calculations, and other aspects for regulatory submissions.

• Providing input to the Regulatory Intelligence function and participating in readability testing.

• Reviewing IMPD/IB Core Docs and labeling for clinical trials.

• Collaborating with Regulatory Submissions team or cross-functional teams based on project size and nature.

• Facilitating business development activities as needed.

Your profile

• Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred.

• Minimum of 2-3 years of experience in regulatory affairs within the pharmaceutical or biotechNlogy industry.

• Proficiency in regulatory submission processes and requirements, including CT/IND, MAA/NA, variations, DSUR, PSUR, and renewals.

• Familiarity with label review, translation requirements, and regulatory intelligence activities.

• Strong attention to detail and excellent communication skills.

What ICON can offer you:

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our

careers site

to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

Are you ready for a new beginning?

We need your talent, knowledge and dedication to better our world with biology.

Our purpose points the way

In Novonesis, we know that solutions rooted in biology can help solve humanity's biggest challenges. Since we began more than a century ago, this has been our guide. It's how we've gotten so far. And it's how we'll impact the future. Now, more than ever, the world needs change. And with biosolutions, the possibilities for transformation are endless.

We're here to better our world with biology.

Regional Regulatory Affairs Manager - Household Care & Industrial Biosolutions

Are you ready for a new beginning?

We need your talent, knowledge and dedication to better our world with biology.

Our purpose points the way

In Novonesis, we know that solutions rooted in biology can help solve humanity's biggest challenges. Since we began more than a century ago, this has been our guide. It's how we've gotten so far. And it's how we'll impact the future. Now, more than ever, the world needs change. And with biosolutions, the possibilities for transformation are endless.

We're here to better our world with biology.

Join us as our new Regional Regulatory Affairs Manager for Household Care and Industril Biosolutions

Are you ready to make a real-world impact with your science background? Do you enjoy staying on top of regulations and liase the regulatory needs with stakeholders and regulatory authorities? Then this role might be for you

We are expanding our Regulatory Affairs (RA) Global Household Care & Industrial Biosolutions (HHC & I) team in Brazil, to handle the exciting increase of activities within our area in North America and LATAM. Therefore, we are looking for a proactive, curious, motivated and creative colleague to join our team and grow with us.

As our new Regulatory Affairs Manager, you will join the team based in Valinhos, SP (Brazil), working primarily with Household Care portfolio in North America and LATAM and with Bioenergy biosolutions in LATAM.

Welcome to the Regulatory Affairs, HHC & I Team

The Regulatory Affairs HHC & I team operates within a dynamic global framework, delivering strategic and hands-on regulatory support to Novonesis' Planetary Health business. Our mission is to enable the development and launch of safe, compliant biosolutions that make a difference for customers worldwide.

Our team consists of 10 dedicated professionals, each contributing unique expertise and diverse cultural perspectives. This diversity fuels our innovation and enhances how we collaborate, learn, and grow together, all united by a shared commitment to excellence.

At Novonesis, we believe in empowering our people—your growth will be nurtured through meaningful collaboration, continuous learning, and opportunities to expand your regulatory expertise across regions and industry segments.

In This Role You'll Make An Impact By

• Driving regulatory strategies for HHC & I in the Americas and Bioenergy in Latam to secure timely approvals and compliance.
• Monitoring chemical regulations in Brazil, Colombia, Peru, and Chile; representing NVS RA HHC & I in external working groups and trade associations.
• Leading dossier preparation for new registrations and renewals.
• Supporting annual tonnage reporting for the Americas.
• Ensuring product documentation (SDS, labels, technical files) meets regional and global standards.
• Managing regulatory data in RegOne and internal systems.
• Coordinating documentation with global/local teams for submissions.
• Supporting chemical inventory management and tracking regulatory status in NA and Latam.
• Engaging early with local stakeholders for proactive regulatory alignment.

To Succeed You Must

• Hold a Bachelor Degree in a relevant field, Biotechnology, Biology, Chemistry, Microbiology or other related Scientific disciplines. A MSc or equivalent in Chemistry or related field is a plus.
• Over 7 years experience in regulatory, with extensive experience within Home Care industry or related industries.
• Have expertise representing the company in trade associations and with local regulatory authorities (i.e. ANVISA, CTNBio, VISA, among others).
• Expertise in GMM dossier is a plus.
• Skilled in translating biotech concepts into regulatory terms
• Clear communicator with strong stakeholder engagement
• Proactive, results-driven, and quick to adapt
• Comfortable working independently and in teams
• Enjoys informal, multicultural environments
• Experienced in global coordination
• Native Portuguese speaker, fluent in English and Spanish, including reading, writing, and speaking.

Location: Valinhos, São Paulo, Brazil

Deadline: 25th of September. We will screen and invite for interviews on an ongoing basis, so please submit your application as soon as possible.

Contact details: If you want to know more about the position, you are more than welcome to contact, Head of Global RA, HHC & I , Kelly Seligman on

Could our purpose be yours? Then apply today

At Novonesis we commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We recommend you not to attach a cover letter to your application. Instead, please include a few sentences in your resume/CV about why you are applying. To ensure a fair recruitment process, please refrain from adding a photo in your resume/CV.

Novonesis is dedicated to fostering a unique community by embracing and respecting differences. We make all employment decisions based on business needs, ensuring that every individual can thrive, regardless of identity or background such as ethnicity, religion, gender, sexual orientation, age, disability, or veteran status.

Want to learn more?

Learn more about Novonesis, our purpose, and your career opportunities at

Not the right fit for you?

Even if this job isn't the right fit for you, perhaps you know someone who might find it interesting. If so, please feel free to share the job link and encourage them to apply. Thank you for your referral Please check out our other open positions. The right fit for you could just be a few clicks away.

Stay alert: Avoid recruitment scams

At Novonesis, we are committed to maintaining a safe and transparent recruitment process. Please be aware of potential scams targeting job seekers and take note of the following:

• Novonesis will never ask for sensitive personal information, such as bank account details, Social Security numbers, or passwords, at any stage of the hiring process.
• Novonesis does not make employment offers without conducting interviews with candidates.

If you receive suspicious communication claiming to be from Novonesis, please do not share any personal or financial information. We encourage you to verify the legitimacy of the message by contacting us directly through our official channels.

Regulatory Affairs Specialist Post Register - Home based - São Paulo

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Regulatory Affairs Specialist to join our diverse and dynamic team. As a Regulatory Affairs Specialist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of inNvative treatments and therapies.

What You Will Be Doing

• Undertaking variable duties based on project requirements, primarily within Pharmaceutical, BiotechNlogy, or Biologics Regulatory Affairs, with potential involvement in related areas.
• Contributing to regulatory submissions team activities, including preparation, compilation, and submission of regulatory documents such as CT/IND, MAA/NA, variations/lifecycle submissions, DSUR, PSUR, renewals, and agency briefing documentation.
• Managing and implementing label review, translation requirements, fee calculations, and other aspects for regulatory submissions.
• Providing input to the Regulatory Intelligence function and participating in readability testing.
• Reviewing IMPD/IB Core Docs and labeling for clinical trials.
• Collaborating with Regulatory Submissions team or cross-functional teams based on project size and nature.
• Facilitating business development activities as needed.

Your profile

• Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred.
• Minimum of 2-3 years of experience in regulatory affairs within the pharmaceutical or biotechNlogy industry.
• Proficiency in regulatory submission processes and requirements, including CT/IND, MAA/NA, variations, DSUR, PSUR, and renewals.
• Familiarity with label review, translation requirements, and regulatory intelligence activities.
• Strong attention to detail and excellent communication skills.

What ICON Can Offer You
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function
Regulatory Affairs Group

Job Sub Function
Regulatory Affairs

Job Category
Professional

All Job Posting Locations:
São José dos Campos, São Paulo, Brazil, São Paulo, Brazil

Job Description
The Manager, Regulatory Affairs leads a team of individual contributors and is accountable for conducting effective performance management. The manager is also responsible for regulatory strategies that support the execution of the Wound Closure and Healing portfolio strategy and regularizing the Brazilian manufactured products, ensuring compliance to local and international regulations and ensuring business continuity through the maintenance of compliant and accurate registrations / sanitary licenses. The individual will have end to end responsibility for maintaining existing products in key markets and launch of new/improved products in alignment with portfolio strategy. The Manger will be strategic by considering new and changing regulatory requirements to identify the most effective and efficient strategies for compliance. This position is also responsible for providing direction and leadership to RA team members in the development and execution of global regulatory strategies and processes to ensure timely registration of Wound Closure and Healing products globally.

DUTIES & RESPONSIBILITIES*
Under Limited Supervision And General Direction In Accordance With All Applicable Federal, State And Local Laws/regulations And Corporate Johnson & Johnson, Procedures And Guidelines, This Position

• Coordinates the production and compilation of the required documentation to legally regulate the sanitary registration of the products manufactured in Brazil, in the countries of Latin America (LATAM), Asia, Europe, Africa and USA, and when applicable, carry out the registers directly in the countries of interest.
• Ensure that documentation of products manufactured by Brazil is available when and where customers need it, providing guidance to technical areas, preparing documents in compliance with regulatory requirements, to support both local and international registration, and marketing of the products. products in the public market (biddings) and in the private sector.
• Participate in key projects of the SJDC site, delivering strategies and regulatory results within the agreed time frame in the project schedule.
• Identify and anticipate changes in the national and international health regulatory environment of interest and impact on the business or products of the SJDC site to support the implementation of new or changed health regulations / standards to ensure that the site's products, processes, practices and procedures of SJDC are in compliance therewith.
• Keep updated under the regulatory sanitary aspect, procedures and approvals in the systems of use by the site of SJDC, such as EtQ, Barcode, ADAPTIV, and MDRiM which includes the Preliminary and Final Regulatory assessment, if applicable.
• Interact, establish and maintain communication with health authorities and notified bodies, such as ANVISA, BSI, SABS, TGA and others directly related to the activities of the SJDC site.
• Participate as representative of the Company in national or international forums for discussion and creation of sanitary standards and regulations, of business interest, to contribute positively to the Brazilian regulatory environment.
• Maintain up-to-date licenses / certificates / health authorizations required for the SJC site operations.
• Support inspections, audits, field actions, site-related techno-surveillance, and products manufactured by SJDC.
• Establish strong connections and collaboration with business partners at SJDC and ETHICON USA, such as quality, legal, packaging, manufacturing, market, regulatory affairs.
• Ensure subordinates follow all company guidelines related to Environmental, Health, and Safety practices, and that all resources needed are available and in good condition, if applicable.
• Empower team to act with speed, agility, and accountability.

EXPERIENCE AND EDUCATION*

• Degree in Pharmacy or related areas.
• A minimum of 8 years of working in a Regulatory Affairs preparing submissions for complex devices or other product categories.
• Fluent English.
• Spanish desirable.
• Active affiliation with CRF-SP, able to assume a technical responsible role
• Multi country experience desirable.
• Experience 1 - 2 years direct management.
• Knowledge of regulatory environment such as Brazilian Directives, Medical Devices Directive (MDD), FDA regulations and others
• Analytical problem-solving skills
• Ability to partner within the team and across teams
• Strong communication and presentation skills
• Critical thinking and ability to partner with key stakeholders
• Strong interpersonal and analytical skills to understand technical data/information

LOCATION AND TRAVEL REQUIREMENTS

• Position based in Sao Jose dos Campos or Sao Paulo
• Occasional travel for domestic and/or international territories.

Due to ongoing global expansion, Indero is looking to hire a Regulatory Affairs Specialist. In this position, you will be responsible for preparation and submission of part I and/or part II following EU CTR and other applications created within or outside of the company to ensure documentation comply with applicable regulations and guidelines and contractual timelines are met. You will provide leadership for assigned projects regarding all regulatory activities that lead to start up of clinical trials.

Responsibilities:

• Preparation of regulatory documents, CTA packages, and submissions in assigned countries to ensure high quality standards
• Coordination of regulatory timelines and deadlines for all assigned projects planned for CTIS submissions. Includes oversight of EU (mainly), APAC, and North America submissions.
• Review of regulatory documents and submissions created outside of the company by subcontractors (eg, partner CROs, regulatory vendors) to ensure high quality standards before submission to CTIS
• Point of contact for Sponsors and subcontractors/project management teams for all aspects related to study regulatory submissions
• Preparation or review of country specific Patient Information Sheet/Informed Consent form documents.
• Preparation or review of study-specific templates of regulatory forms.
• Manages translation requests with vendor.
• Regulatory support and advice to project teams and key internal/external customers on local requirements and EU submission strategy and technical expertise
• Maintain high level knowledge about EU CTR and EU/EEA countries local requirements in the area of company interest.
• Maintain the regulatory intelligence database
• Participation in Kick-off meetings, audits, and other project related meetings according to the company / client needs

Requirements:

Education

• Bachelor's degree (or equivalent) in a scientific discipline

Experience

• Minimum of 2-3 years of clinical research experience (in CRO or Pharma) working in Poland regulatory affairs is required
• Experience in initial CTA is essential
• Experience in a sponsor facing role is an asset
• Previous experience with CTIS is an asset
• Hands-on experience preparing, reviewing, and submitting regulatory documentations

Knowledge and skills

• Excellent knowledge of applicable EU regional / national country regulatory guidelines (such as Poland, Spain, Germany, France, Netherlands)
• Excellent knowledge of GCP and ICH standards
• Fluency in English with excellent oral and written skills, required
• Additional languages represent an asset
• Excellent organization and communication skills, great attention to detail
• Ability to organize own work, prioritize different assignments, and work under pressure;
• Versatile and comfortable in a multitasking environment;
• Respect established timelines, expectations, priorities, and objectives;

Our company:

The work environment

At Indero, you will work with brilliant and driven professionals. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

As a Regulatory Affairs Specialist you will be eligible for the following perks:

• Permanent full-time position
• Flexible schedule
• Vacation
• Home-based position
• Ongoing learning and development

About Indero

Indero is a contract research organization (CRO) specialized in dermatology and Rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Romania.

Brand name:

Indero

Regulatory Affairs Manager – LATAM

Job Description:

The Regulatory Affairs Manager – LATAM will serve as a strategic individual contributor responsible for leading regulatory efforts across Brazil and supporting broader LATAM initiatives. This role requires a proactive, forward-thinking approach to regulatory strategy, with the ability to anticipate market trends, navigate complex regulatory landscapes, and influence long-term business success.

Reporting to the Director of Regulatory (U.S.-based), the manager will collaborate with internal teams, external consultants, and government agencies to ensure compliance and enable market access for Elemental Enzymes' portfolio of biopesticides, biostimulants, and biofertilizers.

Responsibilities:

• Develop and execute regulatory strategies for testing, importation, and commercialization of products in Brazil.
• Lead regulatory submissions and manage approval processes with Brazilian authorities (e.g., MAPA).
• Build and maintain project plans, timelines, and documentation for regulatory activities.
• Collaborate with internal stakeholders, consultants, and business partners to align regulatory goals with commercial objectives.
• Serve as the primary liaison with regulatory agencies and consultants, connecting regulatory frameworks with emerging technology.
• Monitor regulatory changes and assess their impact on current and future product registrations.
• Provide strategic foresight to support LATAM expansion and long-term regulatory planning.

Qualifications:

• Bachelor's or Master's degree in Biological Sciences or related field.
• Fluency in Portuguese and English; Spanish proficiency is a plus.
• Demonstrated experience with Brazilian regulatory frameworks for biopesticides, bio-inputs, and fertilizers.
• Proven ability to interact effectively with regulators and manage external consultants.
• Strong written and verbal communication skills.
• High attention to detail and commitment to regulatory compliance.
• Strategic mindset with the ability to solve problems collaboratively.
• Strong negotiation and relationship-building skills.
• Experience managing complex projects and regulatory documentation.

Physical Demands:

• Extending: Extend self in a direction to complete a task.
• Stationary Position: Remaining in one position for sustained periods of time.
• Moving: Moving to accomplish tasks, particularly for long distances or moving from one work site to another.
• Fine Motor Skills: Using fingers for tasks such as typing, picking, or pinching, rather than full hand movements.
• Transporting: Moving objects from a lower to a higher position or moving objects horizontally from position-to-position.
• Manual Handling: Gripping, grasping, or applying pressure to objects using fingers and palms.
• Operating: Using tools and equipment including a work computer and other office devices such as printers, calculators, etc.
• Repetitive motion: Engaging in recurring movements of the wrists, hands, or fingers, such as typing or assembling components.

Physical Requirements:

• Sensory Touch: Assessing the size, shape, texture, or temperature of objects by touch, particularly with fingertips.
• Communicating: Expressing or exchanging ideas by spoken word, including providing detailed or critical instructions clearly, quickly, and accurately. Perceiving sound details at normal speaking levels. Alternative methods of communication can be utilized as necessary.
• Environmental Exposure: The worker is not substantially exposed to adverse environmental conditions and operates primarily in an indoor setting.

Location: Brazil (with travel to MAPA as needed)

Position Type: Full-Time/Regular/Salary/Exempt

Travel Requirement: Up to 40%

Salary: Competitive, based on qualifications and experience

Benefits: In accordance with Brazilian employment laws

About Elemental Enzymes

Elemental Enzymes was founded upon the simple belief that we must do everything we can to improve agricultural performance in a way that not only enables plants to flourish but enriches and renews the planet with eco-friendly and sustainable agricultural solutions. From products that enable effective enzyme, peptide and protein inputs to foliar treatments that hold the promise to renew entire industries, our focus to make a positive difference in the world through people – like you and me. Success is a byproduct of responsible production. That's why Elemental Enzymes works to bring cross-disciplinary scientists and processes together to create novel solutions to practical problems with a shared goal of helping both the plant and the planet.

Apply

Please fill out the application and attach a cover letter and CV/Résumé. References required upon request.