Sanofi · 7 hours ago
Regulatory Strategist
Cambridge, MA
Full-time
Onsite
Senior Level
$147K/yr - $212K/yr
6+ years expSanofi is an innovative global healthcare company dedicated to improving people's lives through science. The Regulatory Strategist will play a crucial role in shaping global regulatory strategies and ensuring compliance throughout the drug development process.
Health CareLife SciencePharmaceuticalTherapeutics
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
Qualification
Required
BS/BA degree in a relevant scientific discipline required
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
Preferred
Advanced degree (PharmD, PhD, MD, or DVM or MSc in Biology, Life Science, or related field) 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
Benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Company
Sanofi
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (83)
2024 (69)
2023 (59)
2022 (78)
2021 (38)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$6.97BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.74B
2025-03-05Post Ipo Debt· $1.59B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
2025-12-30
2025-12-30
Company data provided by crunchbase