Director CMC Regulatory Affairs

Discover International

Manchester

3 months ago

Applications closed

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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.

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