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Regulatory Affairs Director

2 months ago

Santa Clara, California, United States Bayside Solutions Full time

Job Summary:

The position is responsible for providing strategic guidance on CMC regulatory matters and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of pipeline compounds/products.

Key Responsibilities:

  • Develop and implement 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.
  • Collaborate with cross-functional teams to ensure applicable regulatory requirements are met and provide CMC regulatory support for the clinical development of investigational product(s).
  • Work with the corporate regulatory team, CMC SMEs, and CROs to identify regional/country-specific CMC requirements to support global applications and drive the CMC submission timelines to meet business objectives.
  • Participate in interactions with regulatory authorities, such as the FDA, and 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 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, including 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.