Regulatory Strategist

Job title: Regulatory Strategist

Location: Cambridge, MA or Bridgewater, NJ

About the Job

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?

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

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 team’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 life cycle 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.

Qualifications

Education

• 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.

Experience

• At least 6 years of relevant pharmaceutical/biotechnology experience, including at least 4 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.
• Previous regulatory experience specifically supporting Oncology therapeutic area is highly preferred.   
• 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.

Soft and Technical Skills

• 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.
• Experience working in and strong knowledge of electronic document management systems (e.g. Veeva Vault RIM, Plai).
• Demonstrated ability to manage multiple projects/deliverables simultaneously.
• Strong sensitivity for a multicultural/multinational 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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