CMC Regulatory Affairs Consultant
CMC Regulatory Affairs Consultant
Posted on :
25-08-2025
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1 Vacancy
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Job Description
Responsibilities:
- Provide CMC regulatory strategies to support the clinical development and eventual marketing approval of investigational products.
- Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions including initial submission of IND IMPD/CTA NDA MAA and amendments to Health Authorities (HAs) and preparation of responses to queries from HAs.
- Serve as the CMC regulatory representative on project teams provide CMC regulatory support for the clinical development of the investigational product(s) and ensure applicable regulatory requirements are adequately met.
- Work with the corporate regulatory team CMC SMEs and CROs to identify regional and country-specific CMC requirements to support global applications and to drive the CMC submission timelines to meet business objectives.
- Provide regulatory assessment and guidance on CMC-related change controls deviations and investigations throughout the product life cycle.
- Maintain knowledge of the global competitive landscape regulatory environment regulations and CMC guidance providing interpretation to internal stakeholders.
Requirements:
- An advanced degree (MSc or PhD) in Pharmaceutical Science Chemistry Chemical Engineering or a closely related field is desired.
- 10 years of pharmaceutical/biotech drug development experience with 5 years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs and small molecules.
- Experience in leading CMC-related global submissions (IND IMPD/CTA NDA MAA etc.).
- Strong knowledge of US and international GMP quality regulations current industry practices and experience with interpretation and application to development projects and marketed product regulatory issues
- Demonstrated experience in effective collaboration with internal and external stakeholders
- Able to prioritize and manage multiple projects simultaneously in a dynamic company environment.
- Effective written and verbal communication skills and good interpersonal skills
- Global regulatory experience across major regions such as the US EU and APAC is highly preferred.
- Evidence of prior success in Health Authority interactions is a plus.
Employment Type
Full-time
Key Skills
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