Sanofi
Regulatory Strategist
– Cambridge MA / Morristown, NJ
Overview Are you 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. 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), 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.
Responsibilities
Enables the GRL by providing quality regulatory input and position to internal business partners, including clinical development, 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 and for lifecycle management.
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 assigned products, including authoring the briefing document focused on strategy and scientific content, leading the team through meeting preparations, and moderating the meeting itself.
May lead HA meetings and preparations as designated; leads submission team or regulatory sub‑team to ensure NDA/BLA/MAA/Extensions filings meet project timelines and is responsible for developing and updating the core global dossier; collaborates with regional lead when region‑specific submissions apply.
Leads the IND/CTA submission strategy to ensure preparation timelines meet project timelines for clinical trial initiation.
Supports operational and compliance activities for assigned deliverables, develops and executes regulatory submission planning activities, including generating submission content plans, submission tracking, and document management with cross‑functional team and/or alliance partners.
Qualifications
BS/BA degree in a relevant scientific discipline required; advanced degree (PharmD, PhD, MD, DVM, or MSc in Biology, Life Sciences, 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.
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, 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.
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.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affiliated 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, affectionate or sexual orientation, disability, veteran or military status, 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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– Cambridge MA / Morristown, NJ
Overview Are you 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. 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), 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.
Responsibilities
Enables the GRL by providing quality regulatory input and position to internal business partners, including clinical development, 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 and for lifecycle management.
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 assigned products, including authoring the briefing document focused on strategy and scientific content, leading the team through meeting preparations, and moderating the meeting itself.
May lead HA meetings and preparations as designated; leads submission team or regulatory sub‑team to ensure NDA/BLA/MAA/Extensions filings meet project timelines and is responsible for developing and updating the core global dossier; collaborates with regional lead when region‑specific submissions apply.
Leads the IND/CTA submission strategy to ensure preparation timelines meet project timelines for clinical trial initiation.
Supports operational and compliance activities for assigned deliverables, develops and executes regulatory submission planning activities, including generating submission content plans, submission tracking, and document management with cross‑functional team and/or alliance partners.
Qualifications
BS/BA degree in a relevant scientific discipline required; advanced degree (PharmD, PhD, MD, DVM, or MSc in Biology, Life Sciences, 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.
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, 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.
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.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affiliated 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, affectionate or sexual orientation, disability, veteran or military status, 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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