Regulatory CMC Module 3

Location Netherlands
Discipline: Biotechnology
Contact name: Ernest Banor

Contact email:
Job ref: 15561
Published: about 1 month ago

Regulatory CMC Module 3 Dossier Development Vaccines

Authors/drives sections of the CMC dossier and evaluates/ensures that final versions align with requirements and fulfill regulatory agency expectations. Supports the technical functions in the development of responses to health authority questions related to clinical trials and marketing applications. Evaluates and ensures the completeness, accuracy, and compliance of data for all regulatory submissions. Ensures all dossiers are delivered in a timely manner.


  • Lead and execute CMC writing for clinical (CTA, IND) and is involved in writing marketing applications sections (BLA, MAA) for vaccines
  • Support the CMC functional subject matter experts in the development, authoring, and editing of CMC related technical data for inclusion in Modules 2 and 3 of the eCTD
  • Project leadership: independently lead CMC team meetings to resolve reviewer comments on the regulatory dossiers, execute dossier updates and meet regulatory timelines
  • Prepare, review, manage, and lead responses to CMC related questions from regulatory authorities
  • Perform reviews of dossier documents prepared by other team members for completeness, accuracy, and structure
  • Work closely with Regulatory Affairs, Analytical Development, API Process Development, Drug Product Process Development and External Stakeholders to communicate document-specific timelines to team members to ensure timely deliverables


  • PhD with 3+ years relevant experience OR University degree with 6+ years relevant experience
  • Regulatory CMC writing experience in pharmaceutical biologics (vaccines a plus) preferred
  • Understanding of process validation, process development, and process characterization within product life cycle management
  • Proven understanding of regulatory requirements for biologic products (vaccines a plus) as well as experience authoring IND, IMPD and BLA filings
  • Desire and ability to learn and grow
  • Excellent written and oral communication skills with the ability to work collaboratively and independently across international teams
  • The ability to be a strong collaborator and great teammate
  • Ability to work in a fast-paced environment and connect with different functional groups and people at multiple levels
  • Strong communication and personal leadership skills, pro-active and flexible attitude, sense of urgency, excellent collaborator

Location: Leiden, Netherlands

Duration: 1 year (possible extension)


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