Sanofi
Healthcare
GlobalRegulatoryLead
Neural analysis suggests this role is
optimal for Lead candidates.
“Global Regulatory Lead at Sanofi. Skills: Regulatory strategy, Regulatory affairs, Oncology, Health Authority interaction. Lead development and execution of global regulatory strategies. Formulate Global Regulatory Project Strategy”
Industry & Context.
Risk mitigation
What They're Looking For.
Must Have
BSA degree in a relevant scientific discipline, 8-10 years pharmaceutical/biotechnology experience, 6 years Regulatory Affairs experience, Oncology experience, Expert regulatory strategic experience, Experience developing and defending regulatory strategies, Experience leading Health Authority interactions, Experience developing and implementing regulatory strategy, Experience preparing (s)BLA, (s)NDA, or MAA, INDs, Experience negotiating with a national/regional Health Authority, Experience leading filings/registrations, Experience obtaining a regulatory action, Project leadership experience, Experience leading a team, Experience developing internal talent
Nice to Have
Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field)
What You'll Do.
Lead development and execution of global regulatory strategies
Formulate Global Regulatory Project Strategy
Formulate Global Submission Strategy
Formulate core product labeling
Manage life cycle of products
Contribute to Target Product Profile
Align team on mission and prioritization
Set clear expectations for Regulatory Strategy and Plan
Develop a global labeling strategy
and facilitate feedback within GRT
Develop team of Regulatory Strategists
Ensure alignment and communication internally and externally
Advocate regulatory position to governance and committees
Share outcomes to GRT and cross-functional partners
Identify regulatory acceleration opportunities
Take thoughtful risks
Make final decisions on regulatory success rates
Mitigate risks on behalf of GRT
Monitor and interpret global regulatory environments
Leverage expertise in other parts of GRA
Determine updates to regulatory strategy
Lead development of global HA interaction plan
Communicate key outcomes to senior management
Participate in professional associations
Take leadership roles in industry groups
How You'll Work.
Team & Collaboration
Global Project Team; Global Brand Team; Global Regulatory Team; Cross-functional partners; Senior management
Communication Scope
Regulatory position advocacy
Process & Methodology
Project leadership
Full Job Description
**Job title:** Global Regulatory Lead **Location:** Morristown, NJ / Cambridge, MA **About the job** As the Global Regulatory Lead on our Global Regulatory Affairs, Oncology Team, you’ll be fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies for their products in Sanofi’s diversified portfolio in order to meet corporate and business objectives. The GRL is the primary interface and key strategic GRA partner for the Global Project Team (GPT) and Global Brand Team (GBT). Ready to get started? Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. **About Sanofi** We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. ** _Main Responsibilities:_** * Accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS), Global Submission Strategy, and core product labeling in development as well as for life cycle management of products. Responsible for proactively contributing to the Target Product Profile (TPP), ensuring competitive profiles in alignment with the business objectives * Accountable for leading the GRT for fostering team performance by aligning team on mission, prioritization, objectives and setting clear expectations for the Global Regulatory Strategy and Plan, including a global labeling strategy for assigned projects. The role will supervise, coach, and facilitate a feedback culture within the GRT to develop team pe
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