AD / Director - Regulatory Affairs - FSP Team

Job Title: AD / Director - Regulatory Affairs - FSP Team

Job Location: Remote, North Carolina, USA

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

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.