Regulatory Affairs Manager

vor 4 Wochen


Visp, Schweiz Hays (Schweiz) AG Vollzeit

Freelance/temporary employment for a project

Visp, Valais

Start date: asap

Reference number: 796653/1

Responsibilities
  • Author/review CTD module 3.2 sections for biological medicinal products
  • Manage responses to Health Authority (HA) questions
  • Draft/review briefing documents for scientific advice procedures
  • Interact with Health Authorities
  • Lead and coordinate activities to meet submission deadlines
  • Perform regulatory assessments for change controls and deviations
  • Support site-specific regulatory documentation and activities
  • Participate in process improvement projects
Profile
  • Advanced knowledge in Life Sciences and Pharmaceutical Sciences
  • Strong knowledge of CMC requirements for biologics and strong organizational and project management skills
  • Solidexperience in authoring CMC CTD sections
  • Ability to work autonomously and in a team
  • Good communication and interpersonal skills.
  • Analytical and learning skills.
  • Previous experience in a contractor environment is an advantage
  • Good knowledge of MS tools (Word, Excel, SharePoint)
  • Bachelor-s or Master-s degree in relevant fields; higher education preferred. Regulatory Affairs Certification is an advantage
Benefits
  • Further training opportunities
  • Friendly working enviroment
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