Regulatory Affairs Senior Manager

Com um legado único em dermatologia e décadas de inovação de ponta, a Galderma é a líder emergente na categoria de dermatologia, presente em aproximadamente 90 países. Oferecemos um portfólio inovador baseado na ciência de marcas premium e serviços que abrangem todo o espectro do mercado de dermatologia em rápido crescimento através de Estética Injetável, Cuidados Dermatológicos e Dermatologia Terapêutica. Desde a nossa fundação em 1981, dedicamos nossa atenção e paixão ao maior órgão do corpo humano - a pele - atendendo às necessidades individuais de consumidores e pacientes com resultados superiores em parceria com profissionais de saúde. Porque entendemos que a pele em que estamos molda nossas vidas, estamos avançando na dermatologia para cada história de pele.
Procuramos pessoas que se concentrem em obter resultados, abracem a aprendizagem e tragam uma energia positiva. Eles devem combinar iniciativa com um senso de trabalho em equipe e colaboração. Acima de tudo, devem estar apaixonados por fazer algo significativo para os consumidores, pacientes e profissionais de saúde que atendemos todos os dias. Nosso objetivo é capacitar cada funcionário e promover seu crescimento pessoal, garantindo ao mesmo tempo que as necessidades comerciais sejam atendidas agora e no futuro. Em toda a nossa empresa, abraçamos a diversidade e respeitamos a dignidade, a privacidade e os direitos pessoais de cada funcionário.
Na Galderma, damos ativamente às nossas equipes motivos para acreditar em nossa ousada ambição de nos tornarmos a principal empresa de dermatologia do mundo. Com a gente, você tem a oportunidade definitiva de adquirir novas e desafiadoras experiências de trabalho e criar um impacto direto incomparável.

Job Title: Senior Manager Regulatory Affairs, Brazil Head

Location: Sao Paulo, SP

Reports to: Head of Regulatory Affairs LATAM

Job Summary:

The Senior Manager, Regulatory Affairs – Brazil is responsible for leading the regulatory strategy, submissions, approvals, lifecycle management, and compliance activities for the company's portfolio in Brazil. This role ensures timely market access, maintenance of licenses, and compliance with ANVISA regulations across pharmaceuticals, aesthetics, medical devices, and/or consumer health products, as applicable. The position acts as the primary regulatory representative for Brazil, partnering closely with local and global cross-functional teams to support business objectives, product launches, regulatory intelligence, and risk mitigation activities.

Key Responsibilities:

• Develop and execute regulatory strategies to support new product registrations, line extensions, lifecycle management, and business growth initiatives in Brazil.

• Provide regulatory guidance to local and global stakeholders to optimize approval pathways and accelerate market access.

• Assess regulatory risks and propose mitigation plans aligned with business priorities.

• Represent Regulatory Affairs in cross-functional project teams and governance forums.

• Lead the preparation, compilation, review, and submission of regulatory dossiers to ANVISA.

• Ensure timely approvals, renewals, variations, notifications, and post-approval commitments.

• Manage regulatory timelines and deliverables to support product launches and supply continuity.

• Coordinate interactions with ANVISA and other relevant regulatory authorities.

• Oversee the maintenance of product registrations throughout the product lifecycle.

• Ensure implementation of manufacturing changes, labeling updates, site transfers, formulation changes, and other regulatory variations.

• Monitor registration expiry dates and ensure timely renewals.

• Ensure compliance with applicable Brazilian regulations, guidelines, and internal quality standards.

• Support inspections, audits, and regulatory inquiries.

• Collaborate with Quality, Pharmacovigilance, Medical Affairs, Supply Chain, and Legal teams to address compliance matters.

• Maintain inspection of readiness and support remediation activities when required.

• Monitor and assess emerging regulatory requirements, ANVISA resolutions, and industry trends.

• Evaluate regulatory changes and communicate business impact to stakeholders.

• Provide strategic recommendations to ensure ongoing compliance and competitive advantage.

• Build and maintain effective relationships with ANVISA and industry associations.

• Collaborate with Global Regulatory Affairs teams to ensure alignment of regulatory strategies and submission requirements.

• Influence cross-functional decision-making through clear communication of regulatory opportunities and risks.

• Lead, coach, and develop regulatory professionals within Brazil.

• Foster a culture of accountability, collaboration, continuous improvement, and regulatory excellence.

• Manage resource allocation, priorities, and workload planning to ensure achievement of business objectives.

Qualifications:

Education:

• Bachelor's degree in Life Sciences, Pharmacy.

Experience:

• Minimum 10 years of Regulatory Affairs experience within the pharmaceutical, medical device, aesthetics, biotechnology, or consumer healthcare industries.

• Minimum 5 years of people leadership experience.

• Strong experience managing regulatory submissions and approvals with ANVISA.

• Demonstrated success supporting product launches and lifecycle management activities.

• Experience interacting directly with Brazilian health authorities and industry associations.

Skills:

• Deep understanding of ANVISA regulations and regulatory procedures.

• Strong knowledge of product registration, variations, renewals, labeling, GMP, and  post-approval requirements.

• Proven ability to develop regulatory strategies aligned with commercial objectives.

• Strong project management and organizational skills.

• Ability to manage multiple priorities in a fast-paced environment.

• Excellent stakeholder management, negotiation, and communication skills.

• Strong analytical and problem-solving capabilities.

• Portuguese: Native or fluent.

• English: Advanced/Fluent.

• Spanish: Preferred.