Swisslinx
Basel, SWITZERLAND
(on-site)
Posted
10 days ago
Job Function
Legal Support
Description
Job description:- Location: Basel
- Start Date: July 2026
- Duration: Until December 2026
- Workload: 100%
Requirements:
- Coordinate the preparation, submission, and maintenance of regulatory applications for clinical and non-clinical development programs
- Support lifecycle management activities for marketed products, including product information updates and promotional material reviews
- Contribute to the development and implementation of regulatory strategies aligned with business objectives
- Collaborate closely with cross-functional teams to integrate regulatory requirements into development and lifecycle plans
- Support interactions with regulatory authorities, including preparation of briefing documents and meeting coordination
- Act as a local regulatory contact for Swissmedic and ensure submissions meet local requirements
- Manage regulatory authority questions, commitments, and responses in collaboration with internal stakeholders
- Maintain regulatory documentation, submission tracking, and archiving within regulatory systems
- Conduct regulatory research and monitor changes in applicable regulations and guidelines
- Support commercial teams during product launches and throughout the product lifecycle by providing regulatory guidance
Competences:
- Bachelor's degree in Life Sciences, Pharmacy, Biology, Chemistry, or a related scientific discipline
- 3-5 years of experience within Regulatory Affairs in the pharmaceutical industry
- Experience interacting directly with Swissmedic
- Experience with Swiss marketing authorisation applications (MAAs)
- Familiarity with Swissmedic systems, including the Swissmedic Portal and national publication platform
- Solid understanding of drug development and the pharmaceutical regulatory environment
- Experience with lifecycle management and post-approval activities is an advantage
- Strong stakeholder management and cross-functional collaboration skills
- Fluent German and English, both written and spoken
- Strong organisational skills, attention to detail, and the ability to manage multiple priorities in a fast-paced environment
Job ID: 84550557
