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Regulatory Affairs Associate

  • Standort:

    Haarlem, Niederlande

  • Kontakt:

    Quinton Maduro

  • Jobtyp:

    Temp to Perm

  • Kontakt Telefon:

    +31 (0)20 406 97 50

  • Branche:


  • Kontakt-E-Mail:

Our client, a large international generic Pharmaceutical company, is seeking a professional to fulfill a temporary role as a (Senior) Regulatory Affairs Officer, to cover maternity leave.

Job Description:
As a Senior Regulatory Affairs Officer, your primary responsibility will be to compile and maintain the CMC (Chemistry, Manufacturing, and Controls) sections, specifically modules 2 and 3, of medicinal product dossiers for global registrations. These dossiers pertain to medicinal products manufactured in the Haarlem region.


  • Establishing priorities and planning for products within the portfolio.
  • Compiling registration dossiers and variation packages.
  • Gathering and processing data and information from various company departments to ensure dossier compliance and currency.
  • Evaluating change controls for their impact on registrations and implementing necessary dossier updates across multiple markets for products manufactured in Haarlem.
  • Interpreting international regulations and providing guidance on their implementation.
  • Providing coaching and support to other team members.
  • Communicating dossier content to other departments.
  • Offering strategic advice on the submission of registration dossiers and variations in diverse markets.
  • Addressing inquiries from Health Authorities, foreign representatives, third parties, and maintaining strong relationships with external stakeholders.
  • Identifying opportunities for process enhancements and proposing their implementation.
  • Representing Site Regulatory Affairs in cross-functional project teams.


  • Academic background with a focus on chemistry/pharmaceuticals.
  • Several years (preferably ~4) of experience in CMC Regulatory Affairs or in a QA/QC role within the pharmaceutical industry.
  • Proficiency in registration procedures and pharmaceutical regulations.
  • Proficient in both spoken and written English.
  • Comfort working with various software, including Document Management Systems.
  • Strong attention to detail and the ability to prioritize tasks while adhering to established timelines.
  • Excellent communication skills.
  • Capacity to work independently with minimal supervision.
  • Problem-solving abilities and the capability to identify and implement process improvements.
  • A collaborative team player.


  • 6 month contract, with a possibleextension of 2 monthsthroughOxford
  • Salary indication; €4000 - 6000,- based on a fulltime (40 hour) workweek
  • 32 hours is discussable
  • Partly remote work (3 days on-site when working 40 hours)
  • Region; Haarlem

Vacancy number; 23621