What are the responsibilities and job description for the Director, Regulatory CMC position at Vivid Resourcing?
Director, Regulatory CMC
About the Opportunity:
A global, commercial-stage biopharmaceutical company focused on developing innovative therapies for rare diseases is seeking an experienced Director, Regulatory CMC to provide strategic leadership across global CMC regulatory activities.
Reporting into senior Regulatory Affairs leadership, you will lead the execution of global CMC regulatory strategies across development, registration, and lifecycle management, partnering closely with Technical Operations, Quality, Manufacturing, and external regulatory stakeholders. This is a highly visible role offering the opportunity to influence global regulatory strategy while ensuring the timely delivery of complex CMC submissions.
Key Responsibilities:
- Lead Regulatory CMC activities across multiple development and commercial programmes, ensuring alignment with global regulatory strategies.
- Provide strategic oversight for the preparation, review, and submission of CMC regulatory documentation, including INDs, IMPDs, BLAs, MAAs, variations, annual reports, and health authority responses.
- Partner with cross-functional teams to develop and execute global CMC filing strategies throughout the product lifecycle.
- Lead regulatory planning for manufacturing changes, product lifecycle activities, and global submission strategies.
- Assess CMC change controls, determine regulatory impact across global markets, and ensure appropriate submission plans are implemented.
- Act as the Regulatory CMC lead during interactions with global health authorities, including preparation of briefing documents and meeting strategies.
- Drive cross-functional collaboration to ensure regulatory commitments, submission timelines, and health authority responses are delivered on schedule.
- Provide regulatory expertise on evolving global CMC requirements and advise internal stakeholders on regulatory risks and opportunities.
- Champion continuous improvement of regulatory processes, documentation standards, and compliance practices across the organisation.
Candidate Profile:
- Bachelor's degree in a scientific discipline; an advanced degree is advantageous.
- Around 10 years' experience within Regulatory CMC, pharmaceutical development, manufacturing, quality, or related regulatory functions.
- Proven experience leading global CMC regulatory submissions across development, marketing authorisations, and post-approval lifecycle management.
- Strong experience supporting peptide products, injectable drug products, or drug-device combination products.
- In-depth knowledge of global CMC regulations across major ICH markets.
- Demonstrated ability to lead complex regulatory programmes while influencing cross-functional stakeholders at a senior level.
- Excellent project leadership, organisational, and stakeholder management skills.
- Ability to balance strategic thinking with hands-on execution in a fast-paced global environment.
- Experience within rare disease, specialty pharmaceutical, or biotechnology environments is highly desirable.
What's on Offer:
- Senior leadership opportunity within a growing global biopharmaceutical organisation.
- High-profile role with strategic influence across global product development and commercial programmes.
- Collaborative international environment focused on scientific innovation and patient impact.
- Hybrid working model with regular office presence.
- Competitive executive-level salary, performance bonus, equity incentives, and comprehensive benefits package.