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

Apply

Vacancy posted 12 days ago

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