Associate Director Regulatory CMC – Development
$100,000–$137,500 year
On-siteGent, Flanders, Belgium
Job Summary
Develop and execute regulatory strategies for pre-clinical, clinical, and commercial stage programs, coordinating IND, IMPD, CTAs, and MAAs with global regulatory sub-functions. Author, review, and manage responses to regional and global health authorities while overseeing CMC change controls and amendment submissions. Lead the preparation of BLA, J-MAA, and MAA applications alongside scientific briefing documents, investigator brochures, and risk mitigation plans. Collaborate with external partners to ensure timely delivery of regulatory commitments and maintain awareness of submission status across complex, multi-phased projects. Track execution of regulatory plans and provide strategic input into CMC risk assessments aligned with global strategy.
Required Qualifications
- Master's degree or PhD in biotechnology, pharmaceutical sciences or bioengineering
- relevant expertise in CMC development and CMC regulatory dossier development (IND/IMPD/BLA/MAA)
- comprehensive knowledge of pharmacopoeial requirements, ICH guidelines, FDA and EMA/CHMP regulations and guidelines, and other international regulatory requirements
- Fluent in English
Desired Qualifications
- Science oriented, experience with large molecules
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