AD / Director - Regulatory Affairs - FSP Team

Thermo Fisher Scientific • Wilmington, NC

4d • Onsite

About The Position

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.

Requirements

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior