Leadership Role in Regulatory Affairs: Impacting Millions Worldwide
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.
Requirements:
* Manufacturing Expertise: Hands-on experience in manufacturing operations and managing manufacturing changes.
* Leadership Skills: Proven experience in people management and resolving nonconformance issues.
* Detail-Oriented Mindset: Strong attention to detail and excellent organizational skills.
* Communication Skills: Ability to communicate effectively at all levels, particularly with EU and US regulatory bodies.
Qualifications and Experience:
* Educational Background: A minimum Level 8 Degree in Engineering, Science, or a related discipline.
* Professional Experience: At least 5 years in a similar role with experience in EU regulatory bodies regarding applications and submissions, or equivalent international experience.