Gerente de Assuntos Regulatórios

We are seeking a Regulatory Affairs Manager to lead the management of Patient Assistance Programs (PTA, CUP, and EAP) based in Sao Paulo/Brazil. This professional will play a strategic role in coordinating regulatory submissions, liaising with health authorities, ensuring regulatory compliance, and support for doctors so that patients have access to medications under special programs. Work format: Hybrid. Reports to: Director of Quality and Regulatory Affairs.

• Manage the full cycle of regulatory submissions related to Patient Assistance Programs (Post-Trial Access, Compassionate Use, and Expanded Access) with ANVISA, in accordance with RDC 38/2013 and other applicable regulations.
• Ensure compliance with current legislation and company internal policies.
• Act as the focal point with regulatory authorities, internal and external stakeholders, principal investigators, and research centers.
• Coordinate and review regulatory dossiers and supporting documentation for patient assistance programs.
• Monitor national and international regulatory changes related to access programs.
• Ensure the ethical and compliant execution of programs, in line with pharmacovigilance requirements and regulatory best practices.
• Train and guide internal teams on regulatory requirements and procedures applicable to the programs.
• Collaborate with Foreign Trade, Customer Service, Warehouse, Transportation, Procurement, and Commercial areas in program execution.

• University degree in Pharmacy, Biomedicine, Medicine, Life Sciences, or related fields.
• Solid experience in Regulatory Affairs within the pharmaceutical sector, preferably with Access Programs (PTA, CUP, EAP).
• In-depth knowledge of ANVISA regulations;
• Proven experience in preparing and submitting regulatory dossiers.
• Strong ability to manage relationships with internal and external stakeholders.
• Organized, analytical, strategic, and results-oriented profile.
• Experience in people management.
• Fluent English.