CMC Regulatory Operations Associate

GenèveTemporaireChimie, Pharma, Biotechnologie2019-06-21Master / Université
You are experienced in CMC Regulatory Affairs and are looking for a new mandate? Feel free to apply ! You will be responsible to provide support to the regulatory operations team and be in charge of new products.

CMC Regulatory Operations Associate

Your Responsibilities

  • Support the provision of Quality modules for marketing authorisation applications (EU, US), clinical trial applications and for subsequent post approval and life-cycle management activities
  • Contribute to responses to Regulatory Agencies questions for marketing authorization and clinical trial applications regarding Quality modules and other modules as required
  • Provide support in preparation of briefing packages for Regulatory Agencies

Your Profile

  • Master in biotechnology or equivalent is required
  • At least 5 years of experience in CMC development activities for biologics are required
  • Knowledge of eCTD, particularly Module 3 is required
  • Knowledge of regulatory requirements pertaining to the Chemistry, Manufacturing and Control of manufacture and development of biologics is required
  • Excellent project management skills, attention to detail and the ability to work cross-functionally
  • Effective verbal and written communication skills
  • Proficiency in the use of computers and business software applications
  • Good knowledge of GMPs and the know-how to work within a regulated environment in biological manufacturing
  • Good knowledge of oral and written English and French

Votre contact

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