As an integral member of our Quality Unit, you will be accountable for change control assessment, compliance of manufacturing activities vs regulatory filing, provision of regulatory documents and regulatory intelligence and local expertise in RA. Your role : Lead critical SRC topics and SRC related projectsProvide Regulatory expertise for handling of major Regulatory topics to the SRC team and the site representatives.Ensure alignment of local manufacturing activities and GMP documents with regulatory filings.Coordinate the provision of regulatory deliverables to support regulatory submissions and Answers to Objections.Responsible of product portfolio for Lifecycle management activitie and for some Technical regulatory writings.Provide local expertise in compliance and CMC regulatory affairs and constitute the respective sites local point of contact for Merck Serono Regulatory Affairs CMC and for Health Authorities.Responsible for site manufacturing registration renewal(s), provision of related Health Authorities certificates.Responsible for artwork release in Webcenter as Site QA (SQA).Maintenance of the Site Master File. Who you are:Biologist, pharmacist or other Life Science-related discipline, you have a relevant experience in biotechnological manufacturingTraining or education in regulatory, you have 2 to 5 years' experience in interaction with regulatory agencies and posseFluently spoken and written English and French. A third European language would be an advantage.Good editorial and communication skillsOrganisation, structure and coordination have no secret for you You are known for your ability to be purposeful, result-driven and collaborative.