Manpower For our client, a privately held biopharmaceutical company active in the fields of reproductive health, urology, gastroenterology, endocrinology, and orthopedics, we are looking for a Senior Analytical Development Lead. In this role, you will be responsible for ensuring regulatory compliance of CMC activities and documentation, supporting product lifecycle management, and contributing to cross-functional projects in a GMP environment. Main Responsibilities - Ensure regulatory compliance of activities performed on site and of corresponding documentation versus regulatory dossiers approved by countries. - Maintain currency and consistency of regulatory files for Ferring products manufactured on site throughout their product lifecycle - Support manufacturing site and global projects by checking completeness and correctness of project documentation/records from a regulatory point of view. - Prepare/update/review CMC (Chemistry, Manufacturing and Control) regulatory documentation for Ferring products manufactured on site throughout their product lifecycle (e.g. CTD Module 2 / Module 3 authoring and requested regulatory documentation for submission to Health Authorities). - Prepare and review answers to regulatory agency queries received during product registration procedures (new applications, variations, renewals, annual reports, commitments, tenders, etc.). - Provide expert recommendations and decisions on regulatory issues relating to CMC. - QA regulatory review of changes and impacts - Operational activities related to change management system for the site - Monitoring of the regulatory status for variations and specifications to ensure correct implementation on site. - Active preparation during HA inspections - Back up of regulatory staff during absences (variation follow-up) - Build together with HR L&D and update the training material related to QA RA - Back up of regulatory staff during absences (variation follow-up) Requirements - Bachelor's or Master's degree in Life Sciences, Chemistry, Pharmaceutical Sciences, or a related field - 3 to 5 years of experience in the pharmaceutical industry - Experience or exposure to CMC regulatory activities is a strong asset - Good understanding of GMP environment and regulatory requirements - Strong attention to detail and organizational skills Temporary mission for 3 months Location : St-Prex, Vaud, Switzerland Branche: Chemieindustrie Funktion: Forschung und Entwicklung