Regulatory Affairs CMC Manager
Hybrid · Helsingborg, Skåne, Sweden
Job Summary
Regulatory Affairs CMC Manager responsible for end-to-end Module 3/CMC development and lifecycle management, leading CMC strategy in new product development projects, supervising CMC product owners, and collaborating with R&D, Marketing and Supply Chain to produce CTD Module 3/CMC documents for global marketing authorization variations. The role requires technical leadership, cross-functional partnership, and a drive for operational excellence in regulatory affairs within a Helsingborg-based hybrid work setting.
Required Qualifications
- Relevant Bachelor's Degree or higher
- 10+ years experience in regulatory affairs and/or pharmaceutical product development
- Expertise across regulatory classifications including medicinal products and medical devices as it relates to pharmaceutical CMC regulatory affairs
- Knowledge of regulatory frameworks globally as it concerns pharmaceutical product development and CMC requirements
- Experienced in developing and maintaining Module 2.3 and 3 and providing guidance to cross-functional partners in authoring CTD documents
- Strong project and people management skills
- Proficiency in English
Desired Qualifications
- 10+ years experience in regulatory affairs and/or pharmaceutical product development
- Experience across regulatory classifications including medicinal products and medical devices as it relates to pharmaceutical CMC regulatory affairs
- Knowledge of regulatory frameworks globally as it concerns pharmaceutical product development and CMC requirements
- Experience in developing and maintaining Module 2.3 and 3 and providing guidance to cross-functional partners in authoring CTD documents
- Strong project and people management skills
- Proficiency in English
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