Organizational Relationship(s) including to whom the position reports (JD Job Title): Direct Report to Regulatory Affairs Head / Sr. Manager / Manager (as applicable)
Organizational relationships:
- Works closely with local PCO BU teams in country and internal stakeholders
- Works closely with above country support as GRA-I LatAm Regional Hub, Hub Regulatory Strategists, GRA Product Strategists, Submissions Management, GCMC, Medical managers and other relevant support areas involved in product registration and product lifecycle management processes
Position Purpose
- Participate in the planning of Regulatory strategies for products submissions and lifecycle including also the APIs related to products under responsibility
- Coordinate and execute activities related to 1) Dossier planning and submission -paper and/or electronic
- for initial registration and maintenance of Drug products including product renewals for the assigned portfolio(s), 2) Clinical Trial Applications, for country acceptability in terms of content,
according to local regulations and requirements (as applicable). These activities include HA query management.
- Interact with key internal stakeholders, such as Hub Regulatory Strategists, GRA Product Strategists, Submissions Management, GCMC, Quality, PGS and third-party vendors (as applicable), to ensure the regulatory strategies are executed according to the plan in order to permit the business continuity.
- Support the Regulatory Affairs Sr. Managers and Managers (as applicable), in the definition and execution of the regulatory strategies of assigned portfolios
- Work in collaboration across the region to deliver efficiencies in regulatory submissions and processes.
Primary Responsibilities
- Possess understanding of the market regulatory requirements, as well as the regulatory processes.
- Coordinate the activities assigned, related to Drug Product submissions and license maintenance and Clinical Trial submissions (as applicable) to Health a
📌 Regulatory Affairs Coordinator (Suba)
🏢 Pfizer
📍 Suba