Regulatory Affairs Project Manager

Finding the ‘Needle in the Chaystack’ Talent#RegulatoryAffairs

Key Responsibilities

• Lead project management activities for regulatory submissions, including BLA, MAA, IND, NDA, CTA, and post‑marketing applications .
• Co‑ordination of Mod 2 & 3 preparation and finalisation and tracking of module 5.
• Develop and manage submission timelines, deliverables, and milestones across cross‑functional teams (Regulatory Affairs, CMC, Clinical, Nonclinical, Medical Writing, Quality, etc.).
• Coordinate the planning, tracking, and compilation of submission documents to ensure compliance with FDA, EMA, and other Health Authority requirements .
• Serve as the primary point of contact between regulatory teams, internal stakeholders, and external vendors (CROs, consultants, publishing teams).
• Drive risk identification, mitigation planning, and proactive issue resolution to maintain submission timelines.
• Oversee the preparation of regulatory project dashboards, status reports, and senior leadership updates.
• Support inspection readiness and respond to Health Authority information requests.
• Contribute to continuous improvement of submission planning, regulatory operations, and document management processes.

Requirements

• Master or Ph.D. in life sciences, medicine or veterinary medicine.
• At least 10 years Project Management and Regulatory Affairs experience, understanding of FDA and ICH regulations and guidelines.
• Competent with Project Management tools and software.
• Excellent communication skills, strategic thinker, solution oriented.
• Ability to work independently and manage multiple tasks simultaneously.

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Science and Project Management

Industries

Pharmaceutical Manufacturing and Biotechnology Research