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.