Regulatory Strategist

BioSpace; Morristown (NJ); Hybrid; USD 120,000 - 190,000; Full time

Job summary

Sanofi seeks a Regulatory Strategist to steer global regulatory strategy and drive execution of US/EU/global plans with the GRT. You will support HA interactions and coordinate cross-functional teams to align strategy and submissions.

The role requires 6+ years in regulatory affairs across development stages, and a BS/BA in a relevant field; an advanced degree is preferred. This position is based in Morristown, NJ and Cambridge, MA, with hybrid work possible.

Qualifications

• BS/BA in Life Science or related field required.
• Advanced degree (PharmD, PhD, MD, MSc) preferred.
• 6+ years in pharmaceutical/biotech regulatory affairs, global/regional experience.

Responsibilities

• Provide regulatory input to clinical development, commercial and GRT teams.
• Lead or co-lead HA meetings and prepare briefing documents.
• Develop Global Regulatory Project Strategy and align labeling and lifecycle plans.
• Manage NDA/BLA/MAA submissions and timelines across regions.

Skills

Regulatory strategy

Global regulatory

HA interactions

Project leadership

Education

BS/BA in Life Science

Advanced degree preferred

Job description

Location: Morristown, NJ / Cambridge, MA

Job title: Regulatory Strategist

About The Job

As Regulatory Strategist within our R&D team, you will be ready to shape the future of medicine. The race is on to speed up drug discovery and development to find answers for patients and their families, and your skills could be critical in helping our teams accelerate progress.

As a key member of the Global Regulatory Team (GRT) and strategic partner to the Global Regulatory Lead (GRL), you will leverage your regulatory expertise to contribute to the definition of the global regulatory strategy and drive the execution of aligned US, EU, and/or global regulatory strategies for assigned projects, including Health Authority (HA) interactions. You will provide regulatory expertise and guidance on procedural and documentation requirements to the GRT and cross-functional teams, working flexibly within and across regions to ensure the delivery of business objectives.

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.

Join the engine of Sanofi\'s mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

About Sanofi

Were an R&D-driven, AI-powered biopharma company committed to improving peoples 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 peoples lives.

Main Responsibilities

• Enables the GRL by providing quality regulatory input and position to internal business partners, including but not limited to the clinical development teams, commercial and GRT for assigned projects.
• Contributes to the GRT for assigned projects in alignment with the ream\'s one regulatory voice for providing strategic input on the Target Product Profile (TPP), business planning, governance and committees. May be requested to lead GRT meetings.
• Contributes to the development of the Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product labeling for products in development as well as for lifecycle management of products.
• May serve as a regional/local regulatory lead and point of contact with HAs for projects/products in their remit, as needed.
• Accountable for developing the HA engagement and interaction plans for their assigned products, including the authoring of the briefing document focused on the strategy and scientific content, leading the team through meeting preparations and moderating the meeting itself for the projects in their remit.
• May lead HA meetings and preparations as designated.
• Leads submission team or regulatory sub-team to ensure NDA/BLA/MAA/Extensions filings meet the project timelines for product launch and is responsible for the development and update of the core global dossier/collaborates with regional lead where region-specific submissions are applicable.
• Leads the IND/CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiation.
• Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, 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.

About You

• Minimum 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 relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regional and global), in early and late stage, development of multiple modalities; experience within regulatory CMC not directly applicable.
• Demonstrated experience with preparation of (s)BLA/(s)NDA/MAA, INDs/CTAs, HA meeting briefing documents and negotiating with a national/regional HA preferred.
• Experience on multidisciplinary matrixed project teams (e.g. clinical study team) preferred.
• Project leadership experience preferred.

Why Choose Us

• Bring the miracles of science to life alongside a supportive, futurefocused team.
• Discover endless opportunities to grow your talent and drive your career, whether its 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.
• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.

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.

#GD-SG

#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.