Take on a leadership role that impacts millions of lives worldwide as the Manager of Regulatory Affairs.
Your Key Responsibilities:
* Lead and oversee strategy implementation and operations for product registration submissions, progress reports, supplements, amendments, and periodic experience reports.
* Collaborate with regulatory agencies to expedite approvals through direct interaction and clear communication.
* Serve as a liaison between marketing, research teams, and regulatory agencies throughout the product lifecycle.
* Drive product approvals by ensuring timely approval of new drugs, biologics, or medical devices, and maintaining continued approval of marketed products.
* Advise teams 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.