Team Lead Regulatory Affairs (m/f/d)


  • Minimum educational requirements are a Master's Degree in Pharmacy, Chemistry, Biology or another life science
  • More than 8 years of experience in Regulatory Affairs in pharmaceutical industry, preferably with within generics business and including solid leadership experience
  • High proficiency in European legislation and ideally also CH (experience with creation, review and finalization of MA applications as well as variation packages)
  • Good network and experience with Health Authorities in Switzerland and Europe
  • Preferably: Computer literacy (MS-Office-Tools), good understanding of database and document management systems (docuBridge)
  • Leading and developing team members
  • Leading the CMC team and providing CMC support
  • Establishing and maintaining a functional RA-entity in CH/EU-region by integrating internal and external parts of regulatory groups (HQ, CMC-team, Labelling team, ext. consultants)
  • Fulfilling all regulatory activities (new submissions, maintenance, renewals etc.) for marketed products as agreed with Commercial Operations within CH/EU-region
  • Maintaining collaboration with Commercial Operations to contribute to implementation of business goals
  • Improving regulatory affairs team effectiveness within CH/EU regional team and strengthening the collaboration with the RoW-RA-team
  • Integrating and supervising RA functional activities within CH/EU region
  • Monitoring regulatory policies evolution and ensuring compliance focusing on CH/EU region


» Job description


Employer:
Acino Pharma AG
Location:
8050 Zürich-Oerlikon [CH]