The position is responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of pipeline compounds/products.
Duties and 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 PDM regulatory representative on project teams, provide CMC regulatory support for the clinical development of the investigational product(s), and ensure applicable regulatory requirements are appropriately met.
Work with the corporate regulatory team, CMC SMEs, and CROs to identify regional/country-specific CMC requirements to support global applications and to drive the CMC submission timelines to meet business objectives.
Participate in the interactions with FDA and other global regulatory authorities as appropriate.
Provide regulatory assessment and guidance on CMC-related change controls, deviations, and investigations throughout the product life cycle.
Participate in the regulatory process initiatives and improvement activities.
Maintain knowledge of the global competitive landscape, regulatory environment, regulations, and CMC guidance, providing interpretation to internal stakeholders.
Requirements and Qualifications:
An advanced degree (MSc or PhD) in Pharmaceutical Science, Chemistry, Chemical Engineering, or a closely related field is preferred.
15+ 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/small molecules
Experience leading CMC-related global submissions (IND, IMPD/CTA, NDA, MAA, etc.)
Solid 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
Desired Skills and Experience
CMC Regulatory Affairs, oncology, small molecule, drug development, clinical development
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