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QA Regulatory Affairs
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
Senior Analytical Development Lead
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. Missions: - Lead and drive analytical development activities to support product and analytical robustness across development and commercial stages - Design and implement innovative analytical strategies and technologies to enhance QC capabilities and enable deeper process understanding. - Lead and actively contribute to analytical development work end-to-end, including hands-on laboratory activities, process characterization, DoE and data analysis. - Lead or contribute to cross-functional technology implementation, transfer and industrialization projects from development to commercial manufacturing, ensuring analytical readiness, consistency and risk mitigation, in close collaboration with MTS, QC and QA - Drive data-driven approaches, including multivariate data analysis (MVDA, e.g. PCA, PLS), NIR/PAT modelling and advanced statistical methods, to support process understanding and predictive capabilities. - Act as a subject matter expert in analytical development, supporting OOX investigations, troubleshooting and continuous improvement initiatives - Identify, benchmark and implement emerging analytical technologies, in collaboration with external partners and vendors. Profile: - A Master Degree or PhD in Pharmaceutical Sciences, Analytical Chemistry, Chemical Engineering, Data Science, or a related scientific field. - 5+ years of hands-on experience, in analytical development or process development preferably within the pharmaceutical or biopharmaceutical industry. - Strong experience in Design of Experiments (DoE) and data-driven methodologies (DMAIC) - Experience with multivariate data analysis (MVDA, e.g. PCA, PLS) and NIR/PAT data modelling for process understanding and predictive applications. - Proven ability to drive innovation, influence cross-functional teams and deliver results in complex environments - Strong understanding of cGMP regulations, analytical method lifecycle and relevant pharmacopoeial requirements (e.g. Ph. Eur., USP, JP) - Strong interpersonal, verbal, and written communication skills, including interaction at all levels, including senior management - Lean Six Sigma Greenbelt certification - Solid experience with project management, PMP certified is a plus. Temporary mission until the end of year. Potentially renewable. Start date: 1st of July Location: St-Prex, Vaud, Switzerland. Please send us your complete application package (CV, cover letter, employment certificates, and diplomas).