The Regulatory Site Officer (RSO) is responsible to ensure and conduct compliant regulatory CMC (Chemistry, Manufacturing and Controls) activities. The major focus is related to the Marketing Authorization dossiers worldwide for the manufacturing site in collaboration with global regulatory affairs and other internal as well as external functions.
· Supports batch release by following submission and approval to ensure the product regulatory compliance
· Ensures that the CMC dossier is in line with manufacturing and control procedures and with dossiers approved by Health Authorities
· Contributes to site inspections and audits
· Supports product licenses maintenance and site registration
· Reviews and signs-off documents like SOPs or technical reports
· Assesses and manages change control activities with regulatory impact for the site
· Provides regulatory expertise to site projects
· Manages regulatory activities linked to change controls including updating of the 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
· 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
· 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
· Indication when approved variations can be implemented
· Acts as the regulatory interface with Global Regulatory Affairs or with Affiliate Regulatory Affairs for the site
· Ensures the Regulatory surveillance on his/her specific field of competencies and communicates the appropriate information
· Provides results of regulatory indicators applicable to the site
· Ph.D or Master in a science/health field (e.g. Mathematic, Chemistry, Pharmacy, Biology, Biotechnology Sciences etc.) or equivalent
· Knowledge of global regulations/guidelines, key Health Authority/Industry thinking and trends is a must
· 2-5 years of direct Regulatory CMC experience is preferred
· Technical pharmaceutical CMC experience (laboratory, manufacturing, etc.) is desirable
· Experience of manufacturing operations, Biotechnologies, Biological products is a plus
· Capability of resolving strategic technical and regulatory issues
· Should demonstrate initiative, independent thinking, anticipatory foresight
· Strong communication skills
· Ability to make decisions in a highly moving environment
· Business level in German and English (written & spoken)
· 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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.