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

pWe are seeking an experienced bRegulatory Affairs Consultant /b to join our global Regulatory Affairs team. In this role, you will develop, review, and manage regulatory submissions and compliance activities for pharmaceutical products throughout their lifecycle—from clinical development through post-market activities.

You will work collaboratively with cross-functional teams while demonstrating strong independent judgment and operational expertise. /p pThis is a client dedicated role and you will be working from an office 2 days a week (Basel). /p h3Key Responsibilities: /h3 pDevelop, contribute to, and review content and format for regulatory submissions according to Swiss regulatory guidelines, including: /p ulliMajor and minor submissions /li /ul ulliPeriodic Safety Update Reports (PSURs) /li /ul ulliLabel changes and Chemistry, Manufacturing Controls (CMC) variations /li /ul ulliPost-approval commitments, variations, and notifications /li /ul ulliCollaborate with the Swiss regulatory team, Global Regulatory Science, Regulatory CMC, and cross-functional project teams to develop and execute regulatory strategy throughout the product lifecycle, including clinical development, post-market activity,

and life cycle management. /li /ul ulliCoordinate regulatory submission aspects relevant to assigned projects and programs. /li /ul ulliMaintain Swiss labeling (SmPC, PIL, artwork, and packaging in local languages) in alignment with regulatory requirements and global labeling/core datasheet standards. /li /ul ulliDemonstrate strong ability to work both independently and collaboratively within project teams to achieve group goals. /li /ul ulliSupport the Head of Regulatory Affairs Switzerland in regulatory activities as appropriate. /li /ul h3Skills and Qualifications: /h3 ulliUniversity Degree in Life Sciences or related discipline /li /ul ulli5-8+ years of professional experience in Regulatory Affairs (Marketing Authorization Applications and post-approval variations) /li /ul ulliStrong, current knowledge of Swissmedic regulations (mandatory) /li /ul ulliProven experience in preparing

major regulatory submissions and variation packages to Swissmedic /li /ul ulliStrong experience with CTD format and eCTD submission builds /li /ul ulliExperience in biologics and vaccines development - preferred /li /ul ulliKnowledge of Rare Diseases, Autoimmune Diseases, or Oncology therapeutic areas - preffered /li /ul ullibFluent spoken and written German, French and English /b /li /ul