Edelway/Akka Life Sciences is seeking Senior Regulatory Affairs Consultants
We are actively looking for
Senior Regulatory Affairs Consultants
We can offer you roles for our global clients in Zurich or Basel area.
- Gain and maintain access to the market of medicinal products:
- Coordinate and submit Marketing Authorization, license renewal, Product transfers. Collaborate with the Regulatory Affairs team
- Communication with the authority (Swissmedic) and the head office
- Generate and submit Periodic Safety Update Reports (PSURs / PBRERs)
- Create and revise (safety) labelling material / product information of medicinal products in collaboration with Marketing, Corporate, and the RA team
- Coordinate, prepare and submit Clinical Trial Applications (including notification of changes) to Ethics Committees
- Maintain project/variation tracking lists and/or tools, and generate reports of submission activities
- Maintain oversight and accuracy of registered information of each medicinal product. Keep public database of SPC/PI and internal product lists up-to-date with registered product / labelling information
- Provide responses to medical/safety/quality requests from various stakeholders; interrelate with respective Business Units and Medical Information
- Review and approve promotional material, according to national and Corporate requirements as well as to approved product information
- Establish and revise documents of Regulatory Affairs processes in the Quality Management System, and conduct local training
- Comply with national regulations and guidelines, legal, regulatory, quality (e.g., ISO, GxP) requirements and company policies; ensure high ethical conduct
- Pharmacist or life science degree
- 5 years + of experience in Regulatory Affairs and/or Quality Assurance in a regulated industry (pharma or medical devices) or health care
- Solid experience in submissions to health authorities
- Knowledge of GxP, ISO and local quality regulatory requirements.
- Fluency in English and German or French
If this sound like your next challenge, please send me your updated CV in English at email@example.com or call me on +41 58 717 7034.