Regulatory Affairs Manager
vor 1 Monat
- 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
- Advanced knowledge in Life Sciences and Pharmaceutical Sciences
- Strong knowledge of CMC requirements for biologics and strong organizational and project management skills
- Solid experience 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
- Further training opportunities
- Friendly working environment
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