Regulatory CMC Dossier Specialist

Company: Checkmark Labrecruitment
Job type: Full-time
Waar ga je aan de slag - Where will you work
A large pharmaceutical company dedicated to bringing life-saving innovation to global health. You will work in the Dossier Development and Operations team which is responsible for planning, writing, and reviewing the quality part of dossiers for pharmaceutical products.
Wat ga je doen - What will your job be
In this role as Regulatory CMC Dossier Specialist you will lead and excecute CMC writing for clinical (CTA, IND) and is involved in writing marketing applications sections (BLA, MMA) for vaccines? Interested? Apply now!
As Regulatory CMC Dossier Specialist you drive sections of the CMC dossier and ensure that final versions align with requirement and fulfill regulatory agency expectiations. Your key responsibilities:
  • Lead and excecute CMC writing for clinical (CTA, IND) and is involved in writing marketing applications sections (BLA, MMA) 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
  • 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

Wat vragen wij - What are we looking for
For the position as Regulatory CMC Dossier Specialist you have a MSc or PhD degree with at least 3 years of relevant work experience in Regulatory Affairs.
  • Regulatory CMC writing experience in pharmaceutical biologics (vaccines a plus) preferred
  • Proven understanding of regulatory requirements for biological products as weel as experience in authoring IND, IMPD and BLA filling
  • Understanding of process validation, process development, and process characterization within product life cycle management
  • Strong communication skills and desire to learn and grow
  • Fluent Dutch and English language skills
Wat hebben we te bieden - What do we offer
  • Contract via CheckMarkLabrecruitment until the end of this year
  • Salary indication from €3700,- gross per month based on a full-time position
  • Position for 40 hours/week
  • Dayshift
Wil je meer weten - More information
Neem voor meer informatie contact op met Sebastiaan Loriaux: //
Vacaturenummer: 7231

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