Regulatory Operations Consultant

Description du poste

Our client, an innovative pharmaceutical company, is seeking a Regulatory Operations Consultant III to support its growing portfolio in Switzerland. 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