Senior Regulatory Affairs manager – CMC
Senior Regulatory Affairs manager – CMC
Posted on :
26-09-2025
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1 Vacancy
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Job Description
Responsibilities:
- Author and compile CMC sections of regulatory applications including INDs IMPDs CTAs amendments and annual reports.
- Documentation: Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries stability reports and comparability protocols.
- Communication: Support regulatory interactions by preparing responses to CMC-related questions from FDA EMA PMDA and other global health authorities.
- Strategy Implementation: Execute CMC regulatory strategies as defined by regulatory leadership to support clinical trial initiation and advancement.
- Cross-functional Collaboration: Partner with Technical Operations Quality Manufacturing and external vendors to gather verify and compile CMC information.
- Process Development: Contribute to the development of templates processes and workflows to support efficient and compliant CMC regulatory operations.
- Other duties as assigned.
- Bachelors degree with a minimum of 5 years of experience in CMC regulatory affairs including experience with clinical biologics programs or equivalent related experience.
- Hands-on experience authoring and compiling CMC sections of INDs IMPDs CTAs amendments and related filings.
- Strong knowledge of global CMC clinical regulatory requirements and guidelines including FDA EMA and ICH.
- Experience with biologics drug-device combination products (e.g. pre-filled syringes auto-injectors) or diagnostics (companion diagnostics) preferred.
- Excellent attention to detail technical writing organizational and communication skills.
- Ability to manage multiple deliverables and timelines in a fast-paced environment.
- Proficiency with regulatory document management systems.
Employment Type
Full-time
Key Skills
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