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Regulatory Affairs, CMC Consultant

2 months ago

Santa Clara, United States Bayside Solutions Full time

Regulatory Affairs, CMC Consultant

W2 Contract

Location: Redwood City, CA - Hybrid or Remote PST

Job Summary:

In this role, you will be 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 our pipeline compounds and 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 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 and Qualifications:

  • 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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Desired Skills and Experience

Regulatory, CMC, drug development, pharmaceutical, biotech, chemical engineering, GMP, IND, IMPD/CTA, NDA, MAA