AD / Director - Regulatory Affairs - FSP Team
Thermo Fisher Scientific
Thermo Fisher Scientific (PPD) seeks an Associate Director or Director of Regulatory Affairs to lead strategic and operational regulatory oversight for a late-stage global development program. The role encompasses clinical development through market authorization and lifecycle management, requiring strong scientific judgment and cross-functional collaboration.
Responsibilities
- Develop and execute regulatory strategy for assigned programs aligned with global objectives
- Lead regulatory planning including pre-submission activities, dossier strategy, and submissions
- Coordinate cross-functional review of regulatory submissions with clinical, CMC, and commercial teams
- Prepare responses to regulatory assessment questions and support authority interactions
- Identify emerging regulatory risks and develop mitigation plans; represent Regulatory Affairs on development teams
Requirements
- Life sciences, pharmacy, medicine, or related scientific degree; advanced degree preferred
- Significant progressive regulatory affairs experience in pharmaceutical or biotechnology industry
- Strong expertise in European drug development and registration processes
- Demonstrated experience with dossier preparation, submissions, and health authority interactions
- Knowledge of pharmaceutical legislation, ICH guidelines, GCP, and regulatory requirements
- Ability to interpret complex scientific and regulatory information
Vacancy posted 8 days ago
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