A leading Biotech is looking for an experienced Regulatory leader to take over as Country Head of Regulatory. This person would be the main point of contact for RA concerns for the entire country, leading a growing Regulatory team.
Key responsibilities of the RA Head include:
- Coordination of all regulatory activities in accordance with local and global strategic approaches and business requirements
- Close cross-functional exchange on a local and global level (e.g. with management / international approval department, pharmacovigilance, manufacturing, medicine, market and reimbursement, sales and marketing)
- Central contact with the national approval authority for all regulatory matters
- Budget and team lead responsibility
- Member of senior management team
- Close coordination and cooperation with the QP ("qualified person") with regard to regulatory and product complaints and product recalls
Key requirements of the RA Head include:
- University degree in natural sciences, preferably pharmacist
- Language skills in German and English at a business level are essential, good language skills in French and Italian are an advantage
- 7 - 10 years of relevant professional experience, of which at least 3 - 5 in a comparable position
- Excellent past experience with Swissmedic necessary
