Global Regulatory Lead

Job Title : Global Regulatory Lead

Location : Bridgewater NJ or Cambridge MA (ability to work onsite 2+ days per week per hybrid working policy)

About the Job

Our Global Regulatory Team is involved in developing regulatory product strategies for a variety of therapeutic areas, leading regulatory efforts in the development stage and post marketing of drug products.

The Global Regulatory Lead (GRL) is the fully accountable decision maker for the development and 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.

Decisions are made in alignment with the Therapeutic Area (TA) Head, Global Business Unit (GBU) Head and up to the Global Regulatory Affairs (GRA) Leadership Team (LT) as needed.

The GRL is the primary interface and key strategic GRA partner for the Global Project Team (GPT) and Global Brand Team (GBT).

We are an innovative global healthcare company with one purpose : to chase the miracles of science to improve people’s lives.

We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Duties & 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 Global Regulatory Team (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 Head, 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 GRL is the single GRA point of contact for the program and represents GRA at the GPT / GBT and internal governance committees

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.

Accountable for regulatory assessment for Due Diligence activities as applicable through the partnership with Strategy and Business Optimization.

About you

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) is preferred

At least 10-12+ years of relevant pharmaceutical / biotechnology experience, including at least 10 years of relevant Regulatory Affairs experience (regionally and global), in early and late-stage development of multiple modalities.

Experience within regulatory CMC not directly applicable

Demonstrated expert regulatory strategic experience and understanding of the regulatory environment to develop regulatory strategies

Direct experience formulating the regulatory position in collaboration with the GRT and defending innovative regulatory strategies at Global Project Teams or equivalent forum

Extensive 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 at least one (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, CN, JP)

Previous demonstrated experience of global regulatory drug development to at least one major regulatory approval within a major market (US, EU) including leading the regulatory strategy, response team, and labeling negotiations

Previous experience in leading global Health Authority interactions

Significant project leadership experience

Significant experience in managing people both directly or in a matrixed organizational structure

Direct experience with change management / change enabling : leads teams with a solution-oriented mindset in a fast-changing organizational and external regulatory environment

Why Choose Us?

Bring the miracles of science to life alongside a supportive, future-focused team.

Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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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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 and check out our Diversity Equity and Inclusion actions at !