Regulatory Affairs Director: Global Strategy & Execution

Regulatory Jobs; North Carolina; Hybrid; USD 180,000 - 240,000; Full time

Job summary

PPD is seeking an experienced Associate Director/Director of Regulatory Affairs to deliver strategic and hands-on regulatory leadership for a late-stage global development program in a fast-paced biotech setting. Responsibilities include regulatory strategy, lifecycle management, and cross-functional collaboration across global teams.

The role emphasizes ownership, scientific/regulatory judgment and the ability to drive timely, compliant regulatory outcomes, with travel expected to support

Qualifications

• Degree in life sciences, pharmacy, medicine or related field; advanced degree preferred.
• Significant progressive Regulatory Affairs experience with strong EU drug development expertise.
• Experience in strategy, dossier preparation, submission and health authority review.
• Experience coordinating responses to assessment questions with regulatory authorities.
• Knowledge of pharmaceutical legislation, ICH guidelines, GCP and regulatory requirements.
• Strong communication and leadership across functions.

Responsibilities

• Develop and execute regulatory strategy for development programs and lifecycle management.
• Lead planning, pre-submission activities, dossier strategy, and submissions.
• Coordinate cross-functional reviews with Clinical, CMC, Nonclinical, Biostatistics, and others.
• Prepare responses to assessment questions and manage Day 120/180 milestones.
• Interface with authorities and prepare meetings; drive regulatory decisions.

Skills

Regulatory leadership

Dossier preparation

Health authority review

Cross-functional collaboration

ICH guidelines

Education

Degree in life sciences

Advanced degree preferred

Job description

PPD is seeking an experienced Associate Director/Director of Regulatory Affairs to deliver strategic and hands-on regulatory leadership for a late-stage global development program in a fast-paced biotech setting. Responsibilities include regulatory strategy, lifecycle management, and cross-functional collaboration across global teams.

The role emphasizes ownership, scientific/regulatory judgment and the ability to drive timely, compliant regulatory outcomes, with travel expected to support