CHE - RA CMC Associate Manager (m/w/d) 100%

For our client, a renowned pharmaceutical company based in Basel, we are seeking a:

CHE - RA CMC Associate Manager (w/m/d) 100%

Tasks & Responsibilities:

  • Author high-quality global CMC documentation for regulatory submissions throughout the product lifecycle for Biologics projects/products.
  • Apply agreed CMC global regulatory strategies, current regulatory trends and guide-lines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
  • Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source docu-ments in accordance with project timelines.
  • Coordinate, collect, store source documentation needed for direct submission to Health Authorities.
  • Actively participate as a member of the global RA CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.

Must haves:

  • Good oral and written communication skills with a collaborative and patient-focused mindset
  • Ability to work successfully with global project teams and prioritize activities considering timelines and workload
  • Well-developed planning, organizational, negotiation, problem solving and interpersonal skills
  • Computer/IT systems literacy
  • Degree in Science (e.g. Biochemistry, Biology, Biotechnology, Chemistry, Pharmacy) or equivalent. Advanced Degree in Science desirable
  • Experience in regulatory and/or in the pharmaceutical industry preferred
  • Knowledge/experience of regulations, guidelines and product life cycle maintenance desirable
  • Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Ability to critically evaluate data from a broad range of scientific disciplines. Knowledge of the drug development process desirable

General information:

  • Start date: asap
  • Duration: 18 months with 6 month extension possible
  • Location: Basel
  • Workload: 100%

 

Marilu Mercedes
Marilu Mercedes
Telefon: 058 255 31 04

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