Regulatory Affairs Clinical Trial Manager
Our client, an dynamic medium-sized bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a Regulatory Affairs Clinical Trial Manager for 12 months contract based in the Basel area.
The ideal candidate should have 3 years of previous experience working for the pharmaceutical industry being responsible for the compilation and completion of Clinical Trial Applications within an International Regulatory Affairs team.
- Interact with internal departments or teams, affiliates and third parties as required to give regulatory input and guidance for clinical trials and their submission to European and international Health Authorities (HAs)
- Prepare, submit and maintain Clinical Trial Applications (CTAs) to European and international HAs in accordance with the applicable regulatory requirements
- Liaise with internal, regional, affiliate and/or CRO personnel to request and collect appropriate documents and, where applicable, to arrange submission
- Provide advice to Clinical Trial Team members on HA CTA submission processes and other related submissions, such as amendments, End of Trial notifications, etc.
- For applicable countries, liaise with client’s internal, regional, affiliate and/or CRO personnel to manage submissions related to import/export licenses, including following-up on status of submission and providing input to tracking sheets
- Final sign-off of IMP Shipment Approval requests for relevant departments
- Keep country-specific information updated and informs other members of the CTA group accordingly
Qualifications and Experience:
- At least 3 years experience in Regulatory Affairs within a pharmaceutical company
- Degree in life sciences preferably
- Good organizational and communication skills
- Ability to prioritize tasks and work to deadlines
- Excellent spoken and written English; knowledge of any other European language would be an advantage
- Relevant working/residency permit or Swiss/EU-Citizenship required