Beschreibung
Research Development & Sciences
Location: Bern, Switzerland
Start date: months)
Key responsibilities:
Qualifications & Experience:
If this role is of interest to you, or anyone from your network, feel free to send me your CV and expected hourly rate for immediate consideration. I am specialised recruiter taking care of various projects within the Life Sciences Industry.
You can reach me on: or m.dedaj"at"realstaffing.com
*Please note that since the position is in Switzerland, we are only able to work with people who have a European passport or already have a Swiss working permit/citizenship.
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.
Location: Bern, Switzerland
Start date: months)
Key responsibilities:
- Serve as a Regional Regulatory Lead for the assigned product portfolio (Therapeutic area Immunology, Respiratory, Transplant) and countries.
- Align all regulatory activities with regional and global strategies, ensuring compliance with local requirements.
- Communicate effectively to ensure that dossiers meet regional and local content and format requirements.
- Coordinate, compile and track high-quality documentation for submissions, including new license applications and lifecycle activities to enhance connectivity and improve submission and approval timelines. This also involves addressing questions related to regulatory submissions.
- Build strong relationships with regional regulatory agencies, utilizing negotiation and influencing skills for positive outcomes.
- Collaborate with internal functions (e.g., Commercial, Manufacturing, Supply Chain, and Medical Affairs) to enhance connectivity.
- Stay informed about international legislation and guidelines for biological products and related initiatives (e.g., rare diseases, orphan drugs).
Qualifications & Experience:
- A degree in Life Sciences, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous.
- At least 3 years of regulatory experience within the international region, supported by additional pharmaceutical /industry experience.
- Understanding of the scientific principles and technical requirements relevant to the development of a pharmaceutical product and understanding of the principles of GMP and GCP.
- Proficiency in standard regulatory tools : Veeva, DocNet, Trackwise
- Attendance on site at least 20%
If this role is of interest to you, or anyone from your network, feel free to send me your CV and expected hourly rate for immediate consideration. I am specialised recruiter taking care of various projects within the Life Sciences Industry.
You can reach me on: or m.dedaj"at"realstaffing.com
*Please note that since the position is in Switzerland, we are only able to work with people who have a European passport or already have a Swiss working permit/citizenship.
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.