Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health.
The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting M&S teams in the area of regulatory compliance, maintenance of product licenses and technical writing of CMC documents. The team members of the global M&S Services Hub will act as partners in carrying out tasks and fulfilling responsibilities to support quality activities with a focus on technical writing.
Main responsibilities:
Provision of strategic advice to the businesses with regards to regulatory compliance linked to substances including biological products, infectious agents etc (e.g. safety data sheets, classification, packaging & labelling, transport classification, local regulations). This includes monitoring of regulations.
Act with efficiency with the Global Product Stewardship team.
Edit and maintain Safety Data Sheets using our IT tools.
Independent evaluation and validation of substance data for classification and labelling according to international regulations e.g., GHS/CLP, Seveso, and transport regulations.
Documents all product stewardship information including references, reports to track and to justify any modification in the versioning of the documents used by Product Stewardship (SDSs, Hazard Classification Sheets & data).
Conducting substance data searches and evaluating the results. Collecting, documenting and providing data in internal substance databases.
Communicating effectively in written and oral ways, results and conclusions with contacts of sites and business units.
About you:
Experience: 5+ years of industry experience including 2+ years' experience in Product Stewardship.
Soft skills: Be able to work effectively in a team and on your own initiative. Self-starter with the ability to perform under rapidly evolving contexts. Data-based decision maker and methodical in the analysis. Ability to provide clear concise explanations. Able to work independently, team player and networker. Important sense for transversal impact. Ability to communicate effectively, orally and in writing. Knowledge in biologicals is required not a plus
Technical skills: Professional experience in the field of product safety/product stewardship, chemical / biological laws, classification and labelling of hazardous substances. Experience in writing and reading Material Safety Data sheets. SDS-Writing - Certified competent person according to §18 (4) Hazard Substance Ordinance (Germany) Ability to rank relative compliance risks, high sense of responsibility and compliance and prioritize resulting actions. Ability to keep abreast of compliance changes. Strong proficiency in common chemical regulations. Have critical thinking, problem solving & planning skills. Proficiency in SAP-EHS module is needed. Proven experience of interactions of SAP-EHS with SAP based ERP is needed.
Proven experience of SERC – SAP EHS Regulatory Content (now 3E ERC EHS Regulatory Content) is needed. Certified IATA training for Dangerous Goods Transportation is needed. Proven knowledge on toxicological / pharma toxicological backgrounds would be a plus. Knowledge in the use of Artificial Intelligence for the use of designing SDSs would be a plus(e.g. tool from Opesus). Experience on Extended SDS would be a plus. Knowledge on Biocides and Biological agents
Education: Bachelor’s degree in Biological Science (biology, microbiology, Molecular Biology) or technical discipline at minimum.
Languages: Good coordination and communication skills.
Why choose us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowered to propose and implement innovative ideas.
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
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