Regulatory Affairs CMC Module 3 Specialist

Location Leiden
Discipline: Pharmaceutical
Contact name: Sayf Idais

Contact email:
Job ref: 16087
Published: 11 days ago

For one of the biggest pharmaceutical companies worldwide, we are looking for a Regulatory Affairs CMC Module 3 Specialist. You will focus on the writing of the documents. Read further responsibilities below!



  • 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

Start date: ASAP

Duration: 1 year + extension



You will join growing and innovative organization and will be involved in successful projects with customers all over the world. You are part of a multi-disciplinary team that is continuously creating value for their clients. This is a unique opportunity to develop yourself and to grow within the company. You can expect an attractive salary, benefits, and a lot of growth within this organization.


INTERESTED? Reach out to Sayf Idais for more information by contacting +31 (0)20 20 44 502 or