* Salário: R$ 2.000 a R$ 5.000 por mês (estimado)
* O valor exibido é uma estimativa calculada com base em dados públicos e referências do mercado. Não garantimos que este seja o salário oferecido para esta vaga específica.
Área: Outros
Nível: Gerente
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.
- 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.