Associate Director, CMC Regulatory Science

Associate Director, CMC Regulatory Science

Moderna

Basel, Switzerland

The Role:

The Associate Director, CMC Regulatory Affairs-International will be based at the Basel site and as part of a team be responsible for preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, as well as govern CMC submissions and regulatory compliance support for the development of mRNA products. This position will contribute to and support all regulatory activities to provide high quality CMC sections of regulatory documentation. The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on bringing a new generation of transformative medicines for patients. Development of regulatory strategy for the products in our portfolio will be a key success component.

Here’s What You’ll Do:

  • Develop/implement effective CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks
  • Provide guidance for regulatory CMC aspects of product development projects
  • Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines
  • Drive Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions
  • Support the development of regulatory processes and procedures to support CMC components of regulatory submissions
  • Support the creation and maintenance of CMC submission templates
  • Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls
  • Provides interpretation of regulatory guidance documents, regulations and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs
  • Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases)

Here’s What You’ll Bring to the Table:

  • MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required.
  • 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
  • 8+ years of experience in Biologics focused Regulatory CMC
  • Multidisciplinary focus on certain therapeutic areas (vaccines, oncology and/or rare diseases)
  • Strong knowledge of current EU and ROW regulations
  • Strong knowledge of cGMP
  • Strong experience with CTD format and content regulatory filings
  • Exceptional written and oral communication

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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