Skip to main content

RA CMC Officer

Apply here

Peggy Buys
Recruitment Consultant in Kortrijk



Peggy Buys
Recruitment Consultant in Kortrijk


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

Apply now for RA CMC Officer

Resume

Add resume