52 days ago on jobs.kellyservices.ch

Regulatory CMC Associate Manager

Kelly Services (Schweiz) AG

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 Please refer to JobSuchmaschine in your application

Regulatory CMC Associate Manager

Our customer, an international pharmaceutical company with headquarters in Basel, is looking for motivated candidates to strengthen their team.

Regulatory Affairs CMC Associate Manager
Your key responsibilities include:

  • Author high-quality CMC documentation for HA submission
  • Assure technical congruency and regulatory compliance
  • Prepare CMC responses 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
  • Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends
  • Actively participate as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying critical issues

Your background includes:

  • Degree in Science (e.g. Pharmacy, Chemistry, Biology)
  • Work experience in one of the following fields: pharmaceutical technology, biotechnology, analytics, chemistry
  • Knowledge of drug development processes and of regulatory affairs is desirable
  • Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload
  • Strong planning, organizational and interpersonal skills
  • Excellent communication and negotiation skills
  • Fluency in English

Assignment start:        asap
Assignment duration:planneduntil the end of 2017(with a good chance of contract prolongation)
Workload:                     100%
Have you already worked in a scientific field in the area of drug development and would you like to broaden your expertise in regulatory affairs? If in addition you have strong communication and organization skills you are the candidate we are looking for.
Please send your complete application documents (CV, testimonials, diplomas) to Janine Cabrera: Janine.cabrera(at)kellyservices.ch