Sanofi Group Director, Global Regulatory Affairs CMC Biologics- Westborough//MA in Westborough, Massachusetts
This position will lead the Regulatory aspects of Chemistry, Manufacturing and Controls (CMC) for licensed and clinical biological proteins. This position will develop and lead the product strategy and oversee the direction to commercial and development teams. The incumbent will be responsible for overseeing the global regulatory strategy, assuring it is aligned with Health Authority requirements from a global perspective and ensuring that regulatory submissions are on time and of high quality.
Additional duties include coordination with our global manufacturing sites, integration of regulatory strategy with those sites and communication to senior management.
Lead, supervise and coach a team of approximately 8 regulatory professionals and be responsible for their development.
The ability to lead people and projects is essential, as are excellent people skills and experience working in international multidisciplinary and matrix environments.
Major Activities/Key Responsibilities
Leads and manages an RA CMC Team
Supports Global RA objectives
Contributes to global strategy and planning decisions
Manages team and develops staff
Directs RA CMC Teams and provides senior strategic leadership in the following areas
New applications for drugs/biologics
CTA/IND preparation and maintenance
New Drug BLA/MAA/International Marketing Authorizations
Dossier compliance activities
Team responsibilities include:
Assemble Information, track internal progress, address review comments then assemble final package
Manage regulatory databases
Submit to Board of Health (BoH)/Affiliate and track progress
Interact/ liaise with global health authorities on product and CMC topics
Manage and communicate regulatory projects to responsible parties and stakeholders
Point of contact with Global Regulatory Affairs Team Leads
Post Approval Supplements
Regulatory strategy development
Preparing / Reviewing of Submissions – US, EU and Rest of World (ROW)
Notify Reg Ops for publishing and dispatch to BoH
Overseeing BoH Response to Queries – US, EU and ROW
Assess CMC changes for regulatory reportability
Track changes in regulatory database and follow-up with local regulatory representatives on the assessments and submissions of changes
Provide interpretive analyses regarding impact of complex regulatory guidance documents, regulations, or directives that impact company products and operations.
University degree in a scientific discipline with 10+ years of regulatory experience
Biologics experience required
Knowledge of FDA and EMA regulations is essential
Proficient in MS Word, Excel, PowerPoint, MS Project
Excellent organizational and communication (written and verbal) skills
Demonstrated ability to successfully work on and lead project teams
RAC certification preferred
Previous experience working in a fast paced environment on multiple product lines
Biologics manufacturing, Quality experience
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