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Science Talents

RA CMC Officer

4 days left to apply

RA CMC Officer

Job description

  • Provide timely preparation high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.
  • Author high- quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines.
  • Prepare CMC response to health authority questions during development, registration and product lifecycle
  • Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
  • Identify content, quality and/or timelines issues with source document
  • Keep knowledge up to date with regard to regulatory guidelines

Profile

  • Master degree in Science (e.g Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent or PhD
  • Dutch, English fluent / oral and written
  • Regulatory experience preferred, and/or experience in drug/biopharmaceutical
  • Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology.
  • Ability to critically evaluate data from a broad range of scientific disciplines
  • Knowledge of regulatiions, guidelines for NCE’s and product life cycle maintenances is a plus
  • Ability to work successfully with extended, multinational project team on multiple projects
  • Excellent planning, organizational and interpersonal skills
  • Excellent written/ spoken communication and negotiation skills

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Science Talents | Puurs Sint-Amands 2870

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    4 days left to apply

    Characteristics

    Requirements

    • Master (University or Higher Education Long Type)
    • Dutch

    Offer

    • Full-time
    • Group insurance
    • Company car

    Apply before

    • 7 March

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