vor 3 Tagen

Regulatory Affairs Manager CMC (m/f)

Hays (Schweiz) AG

  • Arbeitsregion
  • Branche
  • Anstellungsart
  • Position

Regulatory Affairs Manager CMC (m/f)

  • Prepare and support DMFs and NDA/MAA/BLA for customers (for small molecules, peptides, ACDs and/or microbial biotech products)

  • Support review, writing and/or approval of site specific regulatory documents

  • Provide regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to ad-hoc questions

  • Keep documented regulatory project plans in line with best practice recommendations

  • Update functional leads and maintain transparency of information across regulatory functions

  • Facilitate and support the implementation of regulatory information management systems within the company and the creation of corresponding business processes within the RA team
  • Life Sciences degree (i.e. chemistry, biology)

  • Profound experience in the pharmaceutical industry in regulatory affairs, especially CMC

  • Understanding of EU and US regulatory requirements for API

  • Experience in working with regulatory authorities

  • Experience in preparing and authoring Module 3 CTD i.e. for IND/IMPD, NDA/MAA

  • Fluency in English, further communication skills in German or French are of advantage, ability to manage priorities and work within tight schedules