Sanofi Group Senior Associate Global Regulatory Affairs CMC in Cambridge, Massachusetts
This position will provide support for Chemistry Manufacturing and Controls (CMC RA) for licensed and clinical biological products. This position may provide input into the product strategy for commercial and clinical teams. Incumbent will be responsible for supporting the defined regulatory strategy which is aligned with Health Authority requirements from a global perspective and assuring regulatory submissions are on time and high quality.
Additional duties include coordination with our global manufacturing sites, integration of regulatory strategy with those sites, communication to senior management and our partners (including Quality and Supply Chain).
Creates collaborative working relationships with Global Regulatory Affairs (GRA CMC &Devices, Regions and Country Regulatory Groups), Technical and Quality Groups within R&D and Industrial Affairs, External Alliance Partners, Project Direction/ Management (R&D Development, Innovation, Pharma Operations teams), Regulatory Health Authorities, Others
Provide support for other CMC projects as needed. Experience working in a matrix environment and excellent people skills are required.
Major Activities/Key Responsibilities
New applications for biologics:
Plan/Prep/Submit/Review support for product dossiers
CTA / IND preparation and maintenance
Recurrent filings: (US, Canadian NDC and YBPR, license and renewals)
Site renewals (ex. Japan Accreditation)
Post Approval Supplements
Regulatory strategy development
Preparing / authoring / review of submissions per Sanofi way of working – US, EU and Rest of World (ROW)
Technical Review of site supporting specific documents (CoA, declarations, etc)
Notify GRA Ops for publishing and dispatch as required
Responses to Health Authority questions – US, EU and ROW
Interaction / liaise with FDA, EMA on CMC topics
Global Regulatory CMC Strategies and risk assessments for development projects and/or marketed products in collaboration with other parts of GRA
Assures positive and collaborative relationships with CMC teams to achieve implementation of appropriate regulatory strategies
Change control assessments
Initiate change in regulatory database and follow-up with local regulatory representatives on the assessments of the change.
Provide interpretive analyses regarding impact of complex regulatory guidance documents, regulations, or directives that impact company products and operations as required.
University degree in scientific discipline with 2- 5 years regulatory experience or equivalent experience
Knowledge FDA regulations is required
Experience with biological and/or small molecule products
Proficient in MS Word, Excel, PowerPoint, MS Project, and IT Systems
Excellent organizational, communication (written and verbal) and negotiation skills.
Analytical, accurate with an eye for detail
Demonstrated ability to work successfully on project teams.
Analyses possible solution using standard procedures
Previous experience working in a fast paced environment on multiple product lines
RAC certification preferred.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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.
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