Description
We are looking for a
Global Project Leader (m/f)
Reference: -en
Start: asap
Duration: 12 MM+
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Erzeugnissen
Your tasks:
- Define and provide optimal global regulatory strategies to support the development/approval of new drugs and life-cycle management activities for assigned products
- Lead creation of regulatory function plans (identification and assessment of regulatory issues)
- Provide interpretation of relevant Health Authority regulatory guidelines
- Lead global submission planning process, creation, review and finalization of key regulatory documents
- Establish and lead regulatory sub-teams and ensure regulatory support for other countries
- Collaborate closely with the US based DRA partner for regulatory considerations
Your qualifications
- Bachelor degree in Life Sciences or PhD
- In-depth experience in Regulatory Affairs
- Good knowledge of regulatory legislation and guidelines (ICH and EU)
- Experience with EMA and NCA as well as with various types of submissions
- Good understanding of regulatory aspects at all stages of development (from phase I to phase IV)
- Familiarity with clinical trial methodology and statistics
- Excellent project management skills and experience in working with cross-functional and global teams
Skills:
- Project manager