Regulatory Affairs Consultant - on-site in Basel (German and French language skills)

The role is a Regulatory Affairs Consultant, working on-site in Basel, for a company that specializes in pharmaceutical products. The company is looking for someone to develop, review, and manage regulatory submissions and compliance activities throughout the product lifecycle, from clinical development to post-market activities. The main day-to-day responsibilities include developing and reviewing content for regulatory submissions according to Swiss guidelines. This involves handling major and minor submissions, Periodic Safety Update Reports (PSURs), label changes, and Chemistry, Manufacturing & Controls (CMC) variations. The role also requires coordinating regulatory submission aspects for assigned projects and maintaining Swiss labeling in alignment with regulatory requirements. Collaboration with various teams, including the Swiss regulatory team and Global Regulatory Science, is essential for developing and executing regulatory strategies. The must-have requirements include a university degree in Life Sciences or a related discipline, 5-8+ years of professional experience in Regulatory Affairs, and strong, current knowledge of Swissmedic regulations. Proven experience in preparing major regulatory submissions and variation packages to Swissmedic, as well as strong experience with CTD format and eCTD submission builds, are also required. Fluency in spoken and written German, French, and English is mandatory. Nice-to-have skills include experience in biologics and vaccines development, as well as knowledge of therapeutic areas such as Rare Diseases, Autoimmune Diseases, or Oncology. The role involves working from an office in Basel for two days a week, and the team is client-dedicated, requiring strong independent judgment and operational expertise. What the role asks for: - University Degree in Life Sciences or related discipline - 5-8+ years of professional experience in Regulatory Affairs - Strong, current knowledge of Swissmedic regulations - Proven experience in preparing major regulatory submissions and variation packages to Swissmedic - Strong experience with CTD format and eCTD submission builds - Fluent spoken and written German, French and English - Experience in biologics and vaccines development - preferred - Knowledge of Rare Diseases, Autoimmune Diseases, or Oncology therapeutic areas - preferred