Regulatory Strategist
Sanofi
Associate Director – Global Regulatory Lead
CSL
full-time
Posted on:
Location: Pennsylvania • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Develop global, integrated regulatory strategies for assigned products with patient-centric focus.
- Act as key GRA representative for Product Strategy Teams (PST) and related global R&D/commercial teams and lead GRAST.
- Directly lead health authority interactions in stationed country (FDA or EMA) and maintain relationships with FDA, EMA, and global authorities.
- Engage and assign tasks to GRAST members to achieve regulatory deliverables and act as regulatory decision maker/approver.
- Review and approve deliverables (e.g., protocol, TPP) from PST, CDT, SMT and related teams; lead discussions at Global Regulatory Forum and with senior management.
- Lead GRA project deliverables (e.g. Core Briefing Books, Orphan Drug Designation, Pediatric Study Plans) and mentor GRAST members.
- Leverage regulatory intelligence/AI, business insights/analytics, and specialized regulatory functions to deliver Global Regulatory Strategy Outlines.
- Foster effective relationships across Global Regulatory Strategy, GRAS Regions and Regulatory CMC, promoting consistency and shared learnings.
- Report to Executive Director Head Regulatory; onsite three days a week in King of Prussia, PA or Zurich, Switzerland office.
Requirements
- Bachelor’s degree (four-year university degree) in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science is required.
- Advanced degree (MS, PhD or MD, DVM) or MBA preferred.
- Minimum of 10 years’ experience in the biotech or pharmaceutical industry.
- At least 5 years regulatory experience, including 3 years working on developmental products.
- Experience in leading teams (preferred 3 years) as a direct or matrix manager.
- Knowledge and understanding of pharmaceutical/biological product development and regulatory requirements in more than one key region (EU, US, Japan).
- Experience working in Regulatory Affairs with direct agency interaction responsibility with at least 1 health authority.
- Relevant experience working in a complex and matrix environment is preferred.
- Strong clinical or device foundation preferred.
- Ability to lead health authority interactions (FDA or EMA) and maintain regulatory relationships.
