Regulatory Affairs Specialist
To coordinate and submit marketing authorization applications and variations to Swissmedic, and to create and revise product labeling; in general to support regulatory activities.
- Gain and maintain access to the market of medicinal products
- Coordinate and submit Marketing Authorization, license renewal, Product transfers and variation applications to Swissmedic. Collaborate with the Regulatory Affairs team
- Generate and submit Periodic Safety Update Reports (PSURs / PBRERs) to Swissmedic
- Create and revise (safety) labeling 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 Swissmedic and 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 / labeling 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
Qualifications and Experience:
- Master’s or Bachelor’s degree in pharmacy, medicine, biology, biochemistry, chemistry, or related disciplines.
- 2 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, preferably Swissmedic.
- Knowledge of GxP, ISO 13485, MDD (as applicable) and local quality regulatory requirements.
- Computer literacy with standard software platforms.
- Marketing authorization applications, clinical trial applications, complaints handling.
- Fluent in German and English both spoken and written is a requirementTakes initiative and is committed to excellence, is able to work under pressure, flexible, and willing to learn.