RA Specialist CMC

Location Leiden, Gemeente Leiden, South Holland
Discipline: Biotechnology
Contact name: Aimee Brenner

Contact email: a.brenner@panda-int.com
Job ref: 13688
Published: 25 days ago

I am urgently recruiting for a Regulatory CMC Module 3 Dossier Developer (Vaccines) to join a leading Biotech in Leiden.

Authors/drives sections of the CMC dossier and evaluates/ensures that final versions align with requirements and fulfill regulatory agency expectations.

Responsibilities

  • 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

Qualifications

  • 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
  • Excellent written and oral communication skills with the ability to work collaboratively and independently across international teams
  • Strong communication and personal leadership skills, pro-active and flexible attitude, sense of urgency, excellent collaborator

Practicalities

  • Duration: End of the year (extension possible)
  • Start date: ASAP
  • Location: Leiden

Interested?

Please apply with your CV. For further information, please contact Aimee Brenner at +31 (0)20 20 44 502 or by email at a.brenner@panda-int.com

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