Job Description

• 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.

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