Regulatory Affairs Manager

About the Role

We are looking for a Regulatory Affairs Manager to lead regulatory submissions and support the development and lifecycle management of pharmaceutical products for the U.S. market.

You will work with Clinical, Quality, Manufacturing, and R&D teams to prepare submission packages, coordinate responses to regulatory questions, and identify risks that could affect development milestones or product approvals.

This role suits someone who combines hands-on submission experience with the ability to manage projects and communicate regulatory requirements to colleagues across the business.

Key Responsibilities

• Develop regulatory plans for assigned products and communicate submission requirements, timelines, and risks.
• Prepare, coordinate, and review submissions, including INDs, NDAs or BLAs, amendments, and annual reports, as relevant to the product portfolio.
• Coordinate contributions from internal teams and external partners to deliver complete, consistent submission packages.
• Support FDA interactions, including meeting preparation, briefing materials, and responses to information requests.
• Assess the regulatory impact of manufacturing, clinical, and labeling changes.
• Maintain regulatory documentation and track commitments, submission milestones, and approval status.
• Monitor relevant regulatory developments and explain their implications to project teams.
• Support inspection readiness and regulatory process improvements.

Required Qualifications

• Bachelor’s degree in life sciences, pharmacy, chemistry, or a related discipline.
• At least five years of regulatory affairs experience in pharmaceuticals or biotechnology.
• Hands-on experience contributing to U.S. regulatory submissions.
• Working knowledge of FDA submission processes and relevant ICH guidelines.
• Experience managing submission timelines and coordinating cross-functional contributors.
• Strong scientific writing, document review, and project management skills.
• Ability to explain regulatory risks and recommend practical next steps.

Preferred Qualifications

• Advanced degree in a relevant scientific discipline.
• Regulatory Affairs Certification (RAC).
• Experience supporting FDA meetings or responding to agency questions.
• Exposure to CMC documentation, biologics, or international submissions.

What Success Looks Like

You deliver submission packages on schedule, identify documentation gaps early, and help project teams resolve regulatory questions before they delay key milestones.