Leadership Role in Regulatory Affairs: Impacting Millions Worldwide
You will be at the forefront of managing teams within the Regulatory Affairs Sub-Function, focusing on implementing and controlling policy and strategy. Your contributions will be crucial in navigating regulatory processes.
Your Key Responsibilities:
* Guide the implementation and operations for product registration submissions, progress reports, supplements, amendments, and periodic experience reports.
* Expedite approvals by interacting directly with regulatory bodies, ensuring clear communication.
* Act as the regulatory representative throughout the product lifecycle, working closely with marketing, research teams, and regulatory agencies.
* Evaluate and ensure timely approval of new drugs, biologics, or medical devices, and maintain continued approval of marketed products.
* Provide expert advice on manufacturing changes, line extensions, technical labeling, and regulatory compliance.
What We're Looking For:
* Hands-on experience in manufacturing operations and managing manufacturing changes.
* Proven experience in people management and resolving nonconformance issues.
* Strong attention to detail and excellent organizational skills.
* Ability to communicate effectively at all levels, particularly with EU and US regulatory bodies.
Qualifications and Experience:
* A minimum Level 8 Degree in Engineering, Science, or a related discipline.
* At least 5 years in a similar role with experience in EU regulatory bodies regarding applications and submissions, or equivalent international experience.