Regulatory Affairs Coordinator

(1450) Opella Healthcare Brazil Ltda; São Paulo; Híbrido; BRL 120 000 - 180 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work arrangement

Resumo da oferta

Opella Healthcare Brazil Ltda is seeking a Regulatory Affairs Coordinator in São Paulo to drive registrations, post-registration filings, and regulatory strategies for Brazil. You will partner with Marketing, Quality and R&D to support portfolio growth while ensuring compliance and timely submissions.

The role requires strong regulatory expertise with medicines, experience in dossiers, and fluent English for global interactions. Hybrid work arrangement is available.

Qualificações

• Strong experience in Regulatory Affairs within the pharmaceutical industry, particularly with medicines.
• Proven expertise in preparing, evaluating and managing post-registration regulatory dossiers and submissions.
• Deep understanding of Brazilian regulatory requirements, including ANVISA regulations and post-registration activities.

Responsabilidades

• Evaluate, prepare and submit product registrations, post-registration petitions and regulatory dossiers to ANVISA in accordance with local legislation and internal procedures.
• Lead technical-scientific assessments, regulatory gap analyses and risk evaluations to support regulatory submissions and portfolio maintenance.
• Execute Life Cycle Management (LCM) activities across the Brazilian portfolio, ensuring compliance and business continuity.
• Collaborate with Global Functions, Marketing, Quality and R&D to develop regulatory strategies and support innovation projects.
• Review promotional and advertising materials to ensure compliance with current legislation and internal standards.
• Monitor regulatory changes, competitor activities and emerging trends, assessing their impact on the business.
• Participate in regulatory discussions, cross-functional meetings and interactions with external stakeholders when required.

Conhecimentos

Regulatory Affairs

ANVISA regulations

Dossier submissions

Cross-functional collaboration

Life Cycle Management

Regulatory risk analysis

Formação académica

Pharmacy / Life Sciences degree

Descrição da oferta de emprego

Regulatory Affairs Coordinator

Location: São Paulo

You’ve built experience, now use it where technical expertise meets business impact. At Opella, we’re challenging how self-care works for millions of people and need regulatory professionals ready to shape what’s next. As a Regulatory Affairs Coordinator, you’ll bring your scientific knowledge, regulatory expertise and collaborative mindset to help ensure compliance, support innovation and enable the growth of our portfolio across Brazil.

About the Job:

• Play a critical role in maintaining and expanding a diverse portfolio of medicines, food supplements and healthcare products in Brazil.
• Partner closely with marketing, innovation, quality, R&D and global teams to bring products and ideas to market.
• Act as a trusted regulatory expert, influencing decisions through technical excellence and business partnership.
• Navigate complex regulatory environments while helping teams make informed, compliant and pragmatic decisions.
• Thrive in a highly collaborative culture where curiosity, simplicity and teamwork are valued.

Main Responsibilities:

• Evaluate, prepare and submit product registrations, post-registration petitions and regulatory dossiers to ANVISA in accordance with local legislation and internal procedures.
• Lead technical-scientific assessments, regulatory gap analyses and risk evaluations to support regulatory submissions and portfolio maintenance.
• Execute Life Cycle Management (LCM) activities across the Brazilian portfolio, ensuring compliance and business continuity.
• Collaborate with Global Functions, Marketing, Quality and R&D to develop regulatory strategies and support innovation projects.
• Review promotional and advertising materials to ensure compliance with current legislation and internal standards.
• Monitor regulatory changes, competitor activities and emerging trends, assessing their impact on the business.
• Participate in regulatory discussions, cross-functional meetings and interactions with external stakeholders when required.

About You:

• Strong experience in Regulatory Affairs within the pharmaceutical industry, particularly with medicines.
• Proven expertise in preparing, evaluating and managing post-registration regulatory dossiers and submissions.
• Deep understanding of Brazilian regulatory requirements, including ANVISA regulations and post-registration activities.
• Ability to conduct technical assessments, regulatory risk analyses and identify practical mitigation plans.
• Experience collaborating with diverse stakeholders, including marketing, global teams and technical functions.
• Degree in Pharmacy, Life Sciences or a related field.
• Advanced English with the ability to participate in global meetings and communicate effectively in written and spoken contexts.

This is more than the next step in your career, it’s a chance to help reinvent self-care while contributing to products that reach millions of consumers every day. If you’re ready to challenge, collaborate and deliver meaningful impact, we’re ready for you.

We are challengers. We are Opella.

Opella values diversity in all its forms and is committed to fostering a workplace where everyone can belong and excel. We welcome and encourage applications from people of all backgrounds.

About Us:

Opella is the self-care challenger with the purest and third-largest portfolio in the Over The Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide - and counting. At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.

#LI-HYBRID

Opella is the self-care challenger with the purest and third-largest portfolio in the Over The Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide - and counting. At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.