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Regulatory Affairs Specialist - Dossier Development (CMC, module 3)

For one of our clients, we are looking for an experienced Regulatory Affairs Officer who will thrive in a coordinating role. Do you have this experience within a pharmaceutical or biotechnological environment? Then please respond now!

Job Description

Our client has the focus on the discovery, development, manufacturing, and marketing of vaccines.
In this position as RA officer you will ensure that research projects are guided towards clinical product development. You make sure that the right legislation is complied with and you are responsible for all issues regarding CMC.

Responsibilities

  • Coordinate and provide technical oversight for the generation of the CMC dossier of marketing and clinical trial submission.
  • Develop the technical eCTD sections to support Regulatory CMC dossier applications.
  • Authorize sections of the CMC dossier and ensure that final versions comply with regulatory requirements and fulfill regulatory agency expectations.
  • Lead dossier authoring activities for late stage projects for regulatory filings.
  • Develop process and business improvements within own functional organization, and aligns with other departments as needed.
  • Represent the department on multi-functional project development teams to support regulatory filings.

Requirements

  • You have a Masters/PhD degree (optional: with post-doc experience) in a pharmaceutical or biotechnology field
  • Minimum of 3-5 years of working experience as a Regulatory Affairs officer and with CMC
  • Experience with module 2.3 and module 3
  • You have good verbal and written communication skills
  • You are organizational, structured and have technical insight and an eye for detail

Benefits

  • Employment: Start via Oxford Global Resources, realistic long term perspective,
  • Salary indication: €4200- €7000 gross per month
  • Working hours: 32 to 40 hours per week
  • Location: Leiden region
  • Vacancy number: 18472