Work ScheduleStandard (Mon-Fri)
Environmental ConditionsOffice
Job DescriptionJob DescriptionPPD, 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 EnvironmentThe 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.
