Senior Manager, Regulatory Affairs â CMC
Senior Manager, Regulatory Affairs â CMC
Posted on :
11-07-2025
Employer Active
1 Vacancy
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Job Description
Responsibilities:
- The Senior Manager Regulatory CMC Technical Writing and Submission Management role will be responsible for supporting the authoring compiling and management of CMC sections for global regulatory filings.
- This role requires a strong understanding of the drug development process pharmaceutical technology and regulatory requirements while collaborating with cross-functional teams to meet technical writing and submission management objectives.
- Support the CMC regulatory writing for high-quality and compliant regulatory CMC documentation (e.g. INDs CTAs MAAs NDAs and their amendments/variations/supplements as applicable) within defined timelines.
- Support Regulatory CMC submission management.
- Support determination of regulatory and scientific/technical requirements for CMC submissions.
- Maintain knowledge of CMC regulatory requirements for drug development through post-approval and annual updated.
Requirements:
- BS in Chemistry Pharmaceutical Sciences Regulatory Affairs or other relevant fields.
- 3 - 5 years of experience in authoring CMC sections of regulatory filings.
- Demonstrated competency in clear and concise technical writing ability.
- Understanding of CMC manufacturing documentation requirements.
- Experience with regulatory submissions and requirements including eCTD documents required for INDs NDAs and MAAs supplements and briefing documents.
- Ability to read and interpret regulations and guidance.
- Excellent team interaction skills and ability to work successfully in a cross-functional team.
- Ability to work in a dynamic environment with a high degree of flexibility.
- Independent management of projects.
- Well organized flexible and able to communicate effectively within CMC functions and Regulatory affairs both spoken and in writing.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
Key Skills
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