Associate Director / Director Regulatory Affairs Europe (client dedicated)

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Regulatory Affairs Associate Director – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.   PPD, is seeking an experienced Associate Director / Director, Regulatory Affairs – Europe to provide strategic and operational regulatory leadership for a late-stage global development program. The role will have primary responsibility for European regulatory strategy and execution across the European Union, United Kingdom and Switzerland, 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.

Develop and execute European regulatory strategy for assigned development programs, ensuring alignment with global development and regulatory objectives. Lead regulatory planning and execution for the centralized European Marketing Authorisation Application (MAA), 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 EMA 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 EMA, MHRA, Swissmedic and other European authorities as required. Lead or support European paediatric regulatory activities, including Paediatric Investigation Plans (PIPs) and interactions with the PDCO. 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 European 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 with a centralized European MAA, including substantial involvement in strategy, dossier preparation, submission and health authority review. Practical experience preparing and coordinating responses to EMA assessment questions and interacting with European regulatory authorities. Experience with PIP/PDCO activities and EU Clinical