The aim of this job is to support the regulatory CMC activities related to the maintenance of the Marketing Authorization dossiers worldwide for the manufacturing site in collaboration with global regulatory affairs and/or other functions (internal and external).
· Supports batch release by following submission and approval to ensure the product regulatory compliance on his/her site
· Ensures that the CMC dossier is in line with manufacturing and control procedures on site and with dossiers approved by Health Authorities
· Contributes to site inspections and audits
· Suppports product licenses maintenance and site registration
· Supports local registration responsibilities
· Reviews and signs-off documents like SOPs or technical reports
· Assesses and manages change control activities with regulatory impact on his/her site
· Provides regulatory expertise to site projects
· Manages regulatory activities linked to change controls for his/her site(s) including updating of CMC files
CMC Documentation management
· Supports Marketing Authorisations worldwide (territory extensions, renewals, site registrations and transfers, new submissions) by writing and approving the corresponding CMC documents/dossiers and collecting GMP related documents from his/her site(s)
· Optimizes the content of CMC dossiers to facilitate the management of future changes
· Facilitates the introduction of new products, process technologies and continuous improvement projects from his/her site(s)
· Writes ready for submission CMC regulatory documents/dossiers to be dispatched to regulatory affairs functions and supports CMC writing performed for other entities (internal or external)
· Prepares with contribution of site experts answers to questions from Health Authorities
· Consolidates all regulatory activities via good planning
· Ensures appropriate personnel at his/her site impacted are notified following Regulatory Authorities
· approvals, indicating when approved variations can be implemented
· Acts as the regulatory interface with Global Regulatory Affairs or with Affiliate Regulatory Affairs for his/her site
· Ensures the Regulatory surveillance on his/her specific field of competencies and communicates the appropriate information to his/her site
· Provides results of regulatory indicators applicable to his/her site
· Ph.D or Master in a science/health field (eg, Analytical, Chemistry, Pharmacy, Biological/Biotechnology Sciences etc.), or equivalent, is desirable
· Technical pharmaceutical CMC experience (laboratory, manufacturing, etc.) is desirable
· Typically, 1-5 years of direct Regulatory CMC experience is preferred
· Experience of manufacturing operations, Biotechnologies, Biological products is a plus
· Must have knowledge of global regulations/guidelines, key Health Authority/Industry thinking and trends, and be capable of resolving strategic technical and regulatory issues
· Should demonstrate initiative, some independent thinking, anticipatory foresight, and be able to communicate effectively to internal and external audiences
· Ability to make decisions in a highly moving environment
· Fluency (oral and written) in English language is strongly recommended
· An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
· An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management).
· An individual and well-structured introduction and training of new employees.
· You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.
· As a globally successful and constantly growing company, Sanofi provides international career paths as well.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life