Regulatory Strategist
Bridgewater, New Jersey, Cambridge, Massachusetts
Overview
From Research and Development to Sales and Marketing, Sanofi offers a wide range of possibilities. Discover our open positions and become a health journey partner.
Success Profile
Do you have what it takes for a successful career with Sanofi?
- Courageous
- Results-driven
- Proactive
- Problem-Solver
- Leadership
- Team player
Culture: Play to Win
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Growth
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Innovation
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Efficiency
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Collaboration
Benefits
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Health & Wellness
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
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Financial
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
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Culture
At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.
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Work/Life Balance
Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.
Quote
"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."
Shannon Resetich
US Head Rare Diseases & Blood Disorders
"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."
Mouhamed Gueye
US Head Medical Rare Blood Disorders
Responsibilities
Job title: Regulatory Strategist (RS)
Report to: Global Regulatory Lead (Anu Mahashabde)
Knowledge, Skills & Competencies:
Proactively contribute with curiosity and openness to diverse perspectives
Understanding of clinical development of drugs and/or innovative biologics products
Demonstrated experience with driving the preparation of regulatory documents (e.g. (s)BLA/(s)NDA/ MAA, INDs/CTAs, Health Authority meeting briefing documents) and negotiating with a national/regional Health Authority
Emerging business acumen, leadership, influencing and negotiation skills
Ability to use appropriate interpersonal styles and techniques to build internal and external networks and lead discussions with internal and external stakeholders.
Effective communication skills, specifically strong oral and written presentation skills
Lead operational and compliance activities for assigned deliverables, develop, execute and maintain including generating submission content plans, submission tracking, and document management utilizing the support and input of cross-functional team and/or alliance partners where relevant
Experience working in and strong knowledge of electronic document management systems (e.g. Veeva vault, Plai)
Demonstrated ability to handle multiple projects/deliverables simultaneously
Strong sensitivity for a multicultural/multinational environment
Qualifications :
BS/BA degree in a relevant scientific discipline required. Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) preferred
At least 6 years of prior pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global) especially in development phase
Experience with clinical development of drugs and/or innovative biologics products
Demonstrated experience with preparation of (s)BLA/(s)NDA/ MAA, INDs/CTAs, Health Authority meeting briefing documents and negotiating with a national/regional Health Authority preferred
Experience on multidisciplinary matrixed project teams (e.g. clinical study team) preferred.
Project Leadership experience 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.
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Pursue progress, discover extraordinary
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!
