Regulatory Strategist

About the role

Brings regulatory expertise to shape the future of medicine. Works at the intersection of lab science and AI-powered discovery, collaborating across boundaries to drive breakthroughs.

Main Responsibilities

• Provides quality regulatory input and position to internal business partners, including 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 strategic input on the Target Product Profile (TPP), business planning, governance, and committees.
• Develops the Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product labeling for products in development and lifecycle management.
• Serves as a regional/local regulatory lead and point of contact with HAs for projects/products in their remit, as needed.
• Led HA engagement and interaction plans for assigned products, including authoring briefing documents focused on strategy and scientific content, leading team through meeting preparations, and moderating meetings.
• Leads submission teams or regulatory sub-teams to ensure NDA/BLA/MAA/Extensions filings meet project timelines for product launch and develops core global dossiers, collaborating with regional leads where region-specific submissions are applicable.
• Leads IND/CTA submission strategy to ensure preparation timelines meet 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 support and input of cross-functional teams 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

• Supportive, future-focused team environment.
• Incredible opportunities for growth and development.
• Comprehensive rewards package.
• Health and wellness benefits.
• Pioneering biopharma company engaged with patients early in drug development.
• Use of cutting-edge AI, data, and digital platforms.
• Opportunities to improve the lives of millions of people globally.

Sanofi Inc. and U.S. Affiliates

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.