Senior Regulatory Project Manager in Edinburgh

Allerton Bishop is delighted to be partnering with an innovative late-stage biotechnology company to appoint a Senior Regulatory CMC Project Manager on a 12-month contract. This is a rare opportunity to play a pivotal role in the development and registration of a novel therapy that is progressing through late-stage clinical development and approaching global regulatory submission.

Working directly with the Vice President of Regulatory Affairs and senior CMC leadership, the successful candidate will lead Regulatory CMC strategy, submission planning, and cross-functional programme execution to support NDA and MAA filings across major global markets. This position offers significant visibility and influence within a highly collaborative biotechnology environment, providing the opportunity to contribute directly to the successful registration and commercialisation of a potentially transformative medicine.

The Opportunity

As Senior Regulatory CMC Project Manager, you will act as the critical interface between Regulatory Affairs, CMC Development, Technical Operations, Quality, Supply Chain, and external manufacturing partners. You will be responsible for driving CMC regulatory activities associated with late-stage development and commercial readiness, ensuring alignment between technical development programmes and global regulatory expectations. A key focus of the role will be supporting the preparation, review, and authoring of CMC documentation required for NDA and MAA submissions.

Key Responsibilities

• Regulatory CMC Leadership
  • Lead Regulatory CMC activities supporting late phase development and registration strategy.
  • Develop and execute global CMC regulatory plans aligned to submission timelines.
  • Act as the primary Regulatory CMC representative across cross-functional project teams.
  • Provide strategic guidance on manufacturing changes, process validation, analytical methods, comparability, stability and lifecycle management activities.
  • Assess regulatory risks associated with technical and operational decisions.
• NDA & MAA Submission Activities
  • Lead preparation, review and authoring of Module 3 documentation for global submissions.
  • Support NDA, MAA, IND, CTA and lifecycle management activities.
  • Coordinate technical contributions from internal stakeholders, CDMOs and external consultants.
  • Ensure consistency and compliance across all CMC submission documents and responses to Health Authority questions and deficiency requests.
• Global Regulatory Strategy
  • Support interactions with FDA, EMA and other international regulatory authorities.
  • Provide guidance on evolving regulatory expectations and industry best practice.
  • Partner with senior leadership to ensure regulatory strategies support accelerated development and commercial objectives.
  • Contribute to inspection readiness and commercial launch planning activities.
• Programme Leadership
  • Drive complex cross-functional CMC deliverables and regulatory milestones.
  • Coordinate internal and external stakeholders to ensure timely execution of submission activities.
  • Support programme governance, timeline management and critical path planning.
  • Manage relationships with CDMOs, consultants and development partners.

Candidate Profile

We are seeking experienced Regulatory CMC professionals with proven expertise supporting late-stage development and commercial registration programmes. Successful candidates are likely to bring experience from biotechnology research, pharmaceutical manufacturers or regulatory consultancy.

Essential Experience

• Significant Regulatory CMC experience supporting small molecule pharmaceutical products.
• Demonstrable experience authoring and reviewing Module 3 documents and involvement in NDA and/or MAA submissions.
• Experience supporting products through late phase development and registration activities.
• Strong understanding of global CMC regulatory requirements including FDA, EMA and ICH guidance.
• Experience leading or supporting successful NDA approvals.