AD / Director - Regulatory Affairs - FSP Team

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job Description

Join Us as a Regulatory Affairs Associate Director – Make an Impact at the Forefront of Innovation.

PPD, is seeking an experienced Associate Director / Director, Regulatory Affairs to provide strategic and operational regulatory leadership for a late-stage global development program.

The role will have primary responsibility for regulatory strategy and execution, from late-stage clinical development through marketing authorization and lifecycle management, while contributing to an integrated global regulatory strategy.

This is a highly visible, hands-on role suited to a regulatory professional who combines strong scientific and regulatory judgment with ownership, pragmatism and the ability to work effectively in a fast-moving, collaborative development environment.

Appointment at Associate Director or Director level will be based on the successful candidate’s experience, regulatory leadership and scope of prior responsibilities.

Key Responsibilities

• Develop and execute regulatory strategy for assigned development programs, ensuring alignment with global development and regulatory objectives.

• Lead regulatory planning and execution including pre-submission activities, dossier strategy, submission readiness, health authority review and lifecycle management.

• Coordinate cross-functional development and review of regulatory submissions, working closely with Clinical, CMC, Nonclinical, Biostatistics, Medical Writing, Pharmacovigilance, Quality, Commercial and other functions.

• Lead preparation of responses to assessment questions, including key review milestones such as Day 120 and Day 180, ensuring clear scientific rationale, consistency and timely delivery.

• Develop regulatory strategies, briefing packages and meeting preparation for interactions with authorities as required.

• Lead or support regulatory activities.

• Provide regulatory leadership for clinical trial activities conducted through CTIS, including initial applications, substantial modifications and ongoing maintenance.

• Identify and communicate emerging regulatory risks, opportunities and requirements, translating them into pragmatic recommendations and mitigation plans.

• Contribute to labeling, product information, Risk Management Plans and other registration or post-authorization activities.

• Represent Regulatory Affairs on development teams and governance forums and contribute to broader global regulatory strategy.

• Build strong partnerships across functions and external stakeholders, facilitating timely decisions and resolving complex regulatory issues through scientific evidence, regulatory judgment and constructive challenge.

• Maintain appropriate urgency and accountability while ensuring regulatory quality, compliance and integrity of decision-making.

Experience and Capabilities

• Degree in life sciences, pharmacy, medicine or a related scientific discipline; advanced degree preferred.

• Significant progressive Regulatory Affairs experience within the pharmaceutical or biotechnology industry, with strong expertise in European drug development and registration.

• Demonstrated experience, including substantial involvement in strategy, dossier preparation, submission and health authority review.

• Practical experience preparing and coordinating responses to assessment questions and interacting with regulatory authorities.

• Strong knowledge of pharmaceutical legislation, procedures, ICH guidelines, GCP and applicable regulatory requirements.

• Ability to interpret complex scientific and regulatory information and translate it into clear, actionable recommendations.

• Strong communication, influencing, negotiation and project leadership skills, with the ability to operate effectively across functions and organizational levels.

• Comfortable working independently, taking ownership of outcomes and remaining closely involved in key regulatory deliverables.

• Collaborative and solution-oriented, with intellectual curiosity, sound judgment and openness to alternative perspectives.

• Able to balance speed and pragmatism with scientific rigor, regulatory compliance and high-quality execution.

Working Environment

The position operates within a global, matrixed organization and requires close collaboration across functions, geographies and external partners. The successful candidate should be comfortable combining the quality and governance expectations of a global organization with the agility, accountability and hands-on approach of an innovative biotechnology development environment.

Domestic and international travel may be required, anticipated at approximately 10–20%, depending on program and business needs.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.