Director CMC Regulatory Affairs

Discover International; Manchester; On-site; GBP 60,000 - 80,000; Full time

Job summary

A prominent regulatory consulting firm in the UK seeks an experienced regulatory professional to lead the global CMC strategy for commercial biologic products. Responsibilities include preparing CMC documentation for global submissions and providing strategic guidance based on extensive knowledge of biologics manufacturing. Candidates should have around 8 years of related experience and strong communication skills. This role offers the chance to work in a dynamic environment while collaborating closely with various technical teams.

Qualifications

• Bachelor’s degree in a relevant scientific field, advanced degree preferred.
• Approximately 8 years of experience in Regulatory CMC or related fields.
• Strong knowledge of biologics manufacturing and regulatory requirements.

Responsibilities

• Lead global CMC regulatory strategy for commercial biologic products.
• Prepare and deliver high-quality CMC documentation for global submissions.
• Provide strategic guidance to cross-functional teams.

Skills

Regulatory CMC strategy

Cross-functional collaboration

Technical writing

Project management

Biologics manufacturing knowledge

Education

Bachelor’s degree

Advanced degree

Job description

Responsibilities

• Lead global CMC regulatory strategy for commercial biologic products, focusing on post-approval changes, lifecycle management, and dossier maintenance.
• Prepare and deliver high-quality CMC documentation for global submissions (e.g., supplements, variations, amendments) supporting manufacturing process changes, analytical method updates, site changes, and supplier modifications.
• Provide strategic guidance to cross-functional teams based on strong understanding of biologics manufacturing, control strategies, comparability principles, and process validation requirements.
• Support data review and regulatory readiness for manufacturing / technical changes, including comparability assessments and process improvements.
• Develop responses to Health Authority questions and contribute to briefing materials for global agency interactions.
• Maintain compliance with global regulations and guidelines (FDA, EMA, ICH Q5–Q12) and monitor evolving regulatory expectations for biologics.
• Collaborate with Technical Operations, Quality, Process Development, and Supply Chain to align regulatory strategies with business and technical priorities.

Qualifications

• Bachelor’s degree in a relevant scientific field (advanced degree preferred).
• Approximately 8 years of Regulatory CMC or related experience supporting biologic drug products.
• Strong working knowledge of biologics manufacturing, analytical methods, control strategies, and post-approval regulatory requirements.
• Proven experience preparing and submitting global post-market CMC changes for biologics (US, EU, and international regions).
• Ability to lead regulatory strategy, influence cross-functional stakeholders, and manage multiple global projects.
• Excellent communication, technical writing, and organizational skills.