Responsibilities
* 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
#J-18808-Ljbffr