Risk & Compliance Officer leading compliance activities and ensuring regulations in Malta for fintech leader. Collaborating with global compliance teams and serving as local DPO.
About the role
- Regulatory Affairs Manager coordinating regulatory submissions and compliance for Patient Assistance Programs in Brazil. Collaborating with stakeholders on program execution while ensuring ethical standards.
Responsibilities
- Manage the full cycle of regulatory submissions related to Patient Assistance Programs (Post-Trial Access, Compassionate Use, and Expanded Access) to ANVISA, in accordance with RDC 38/2013 and other applicable regulations.
- Ensure compliance with applicable legislation and company internal policies.
- Serve as the main point of contact 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 teams 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 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 in English.
Benefits
- Medical insurance
- Dental insurance
- Christmas hamper
- Career development plan
- Life insurance
- Meal allowance
- Transportation allowance
- Day off
- Partnership with SENAC
- Profit sharing (PLR)
- Partnership with SESC
- WellHub
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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