We are seeking an experienced Regulatory Affairs Consultant 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.Key Responsibilities:Develop, contribute to, and review content and format for regulatory submissions according to Swiss regulatory guidelines, including:Major and minor submissionsPeriodic Safety Update Reports (PSURs)Label changes and Chemistry, Manufacturing & Controls (CMC) variationsPost-approval commitments, variations, and notificationsCollaborate 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.Coordinate regulatory submission aspects relevant to assigned projects and programs.Maintain Swiss labeling (SmPC, PIL, artwork, and packaging in local languages) in alignment with regulatory requirements and global labeling/core datasheet standards.Demonstrate strong ability to work both independently and collaboratively within project teams to achieve group goals.Support the Head of Regulatory Affairs Switzerland in regulatory activities as appropriate.Skills and Qualifications:University Degree in Life Sciences or related discipline5-8+ years of professional experience in Regulatory Affairs (Marketing Authorization Applications and post-approval variations)Strong, current knowledge of Swissmedic regulations (mandatory)Proven experience in preparing major regulatory submissions and variation packages to SwissmedicStrong experience with CTD format and eCTD submission buildsExperience in biologics and vaccines development - preferredKnowledge of Rare Diseases, Autoimmune Diseases, or Oncology therapeutic areas - preferredFluent spoken and written German, French and English #J-18808-Ljbffr
Regulatory Affairs Consultant (German and French language skills) in Sachseln Arbeitgeber: Parexel
Parexel ist ein hervorragender Arbeitgeber, der sich leidenschaftlich für die Verbesserung der Gesundheit weltweit einsetzt. In unserem Team in Berlin fördern wir eine Kultur der Zusammenarbeit und des Engagements, in der jeder Mitarbeiter die Möglichkeit hat, an bedeutenden klinischen Studien mitzuwirken und dabei persönliche und berufliche Entwicklung zu erfahren. Wir bieten nicht nur ein unterstützendes Arbeitsumfeld, sondern auch zahlreiche Weiterbildungsmöglichkeiten, um sicherzustellen, dass unsere Mitarbeiter in ihrer Karriere wachsen können.
