Beschreibung
Global Program Regulatory Manager (GPRM) - Oncology - Contract - Basel
Swisslinx are looking for a Global Program Regulatory Manager for a 6 month contract in Basel. It would be working for a large Pharmaceutical company within the Oncology department.
Responsibilities of the role include:
- Implementing and providing input into global regulatory strategy
- Presenting to the regulatory boards
- Interact with regulatory consultants/advisors for strategy input
- Represent DRA on or lead sub-teams
- Determine requirements and set objectives for Health Authority
- Coordinate and plan rehearsals for Health Authority
- Responsible for integrating global strategy
- Identification of issues, gaps and tradeoffs affecting optimal and timely submission and approval
- Coordinate, plan and prepare the submission of dossiers
- Review global dossier summary documents
- Responsible for submission of clinical trial applications and investigational New Drugs
- Participate in negotiations for approvals
- Ensure regulatory compliance
- Responsible for finalization and on time submission of annual reports
Key skills you must bring to this role include:
- Fluency in English
- Science based BS or MS with requisite experience and demonstrated capability
- Experience in regulatory submission and approval processes
- Experience in a global Matrix environment
- Experience with Health Authority negotiations
- 2-4 years involvement in regulatory and drug/biologic development
If you possess the above skills and attributes and are interested in this opportunity, then please send your CV.
Should you require any further information then please do not hesitate to call Jennifer Clark. We look forward to hearing from you.
The Swisslinx Group provides bespoke recruitment solutions for technology, financial and executive positions in Switzerland and the Middle East. With more than twenty years experience our business relationships are driven by integrity, trust and discretion.
Swisslinx AG
Miss Jennifer Clark
Copyright Swisslinx AG 2011