Works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations, and Research & Development (R&D) organizations.
Contribute to the development and implementation of regulatory strategies aligned with corporate goals and timelines. Assist in planning and coordinating regulatory submissions and interactions with health authorities. Prepare, review, compile, and archive regulatory documents, including IND applications, Biologics License Applications (BLA), Regenerative Medicine Advanced Therapy (RMAT) designations, and Marketing Authorization Applications (MAAs).
The Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) serves as the primary local representative to ensure compliance with national pharmacovigilance and regulatory requirements. This dual-role position is responsible for executing PV and RA activities at the local level, supporting the Marketing Authorisation Holder (MAH) in maintaining product compliance throughout its lifecycle.