Gerente de Assuntos Regulatórios

Affairs Manager Position Available – Patient Assistance Programs (PTA, CUP, EAP)

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.

Key Responsibilities:

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.

Requirements:

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.