Global Regulatory Lead

Sanofi•Cambridge, MA

1d•$178,500 - $257,833•Onsite

About The Position

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.

Requirements

BS/BA degree in a relevant scientific discipline required.
At least 8-10 years of relevant pharmaceutical/biotechnology experience, including at least 6 years of relevant Regulatory Affairs experience (regionally and/or global), especially in the development phase, with oncology experience
Demonstrated expert regulatory strategic experience and understanding of the regulatory environment to develop regulatory strategies
Ability to work strategically within a sophisticated, business critical and high-profile development program
Experience being accountable for developing and defending innovative regulatory strategies at Global Project Teams or equivalent forum
Previous experience in leading Health Authority interactions in major markets
Strategic regulatory leadership expertise with experience in developing and implementing successful regulatory strategy and with preparation of (s)BLA, (s)NDA, or MAA, INDs, Health Authority meeting briefing documents and negotiating with a national/regional Health Authority within a major market (e.g. US, EU)
Experience leading filings/registrations and obtaining a regulatory action in a major market(s)
Project leadership experience
Experience leading a team and/or developing internal talent

Nice To Haves

Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) is preferred

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 performance. The GRL is expected to develop a team of Regulatory Strategists (RS) as appropriate.
The GRL is accountable for ensuring alignment and communication internally and externally as “one GRA voice” with TA, GBU Head and up to the GRA LT when needed to advocate regulatory position to governance and committees and shares outcomes to GRT and cross-functional partners as appropriate
Identify opportunities to support the team to identify regulatory acceleration opportunities, take thoughtful risks, accept challenges, and making final decisions on the regulatory success rates and mitigations on behalf of the GRT
The role is accountable for monitoring and interpreting the global regulatory environments and accountable to ensure that it leverages expertise in other parts of GRA (e.g. Regional experts) in order to ensure that most robust strategy possible and is accountable for determining any updates to the regulatory strategy accordingly
Leads development of global HA interaction plan and strategy in collaboration with GRT. Is accountable for the communication of the key outcomes to senior management
Advances the organization’s goals by participating and taking leadership roles in professional associations, industry and trade groups as appropriate for assigned therapeutic area and projects in collaboration with the Regions.