Regulatory Affairs Manager
Take on a leadership role that impacts millions of lives worldwide. Manage teams within the Regulatory Affairs Sub-Function, focusing on policy and strategy implementation.
Your Key Responsibilities:
* Lead and Oversee: Guide strategy implementation and operations for product registration submissions, progress reports, supplements, amendments, and periodic experience reports.
* Collaborate with Regulatory Agencies: Expedite approvals by interacting directly with regulatory bodies, ensuring clear and concise communication.
* Serve as a Liaison: Act as the regulatory representative throughout the product lifecycle, working closely with marketing, research teams, and regulatory agencies.
* Drive Product Approvals: Ensure timely approval of new drugs, biologics, or medical devices, and maintain continued approval of marketed products.
* Advise Teams: Provide expert advice on manufacturing changes, line extensions, technical labeling, and regulatory compliance.
What We're Looking For:
Qualifications and Experience: