Regulatory Strategist

Role Summary

Regulatory Strategist responsible for contributing to global regulatory strategy and enabling aligned US, EU, and/or global regulatory activities for assigned projects, including Health Authority interactions. Provides regulatory expertise and guidance to GRT and cross-functional teams to ensure delivery of business objectives.

Responsibilities

• Enables the Global Regulatory Lead by providing quality regulatory input and position to internal business partners, including clinical development teams, commercial, and GRT for assigned projects.
• Contributes to the Global Regulatory Team's input on strategy and governance; may lead GRT meetings.
• Contributes to the development of the Global Regulatory Project Strategy and ensures alignment with core product labeling for development and lifecycle management.
• May serve as regional/local regulatory lead and point of contact with Health Authorities as needed.
• Develops HA engagement and interaction plans, including briefing documents and leading team meetings.
• Leads HA meetings and preparations as designated; leads submission teams to ensure NDA/BLA/MAA/Extensions filings meet project timelines; develops and updates the core global dossier in collaboration with regional leads.
• Leads IND/CTA submission strategy to align preparation timelines with clinical trial initiation.
• Supports operational and compliance activities for assigned deliverables; develops and executes regulatory submission planning, including content plans, tracking, and document management with cross-functional and alliance partners as relevant.

Qualifications

• BS/BA in a relevant scientific discipline required; advanced degree (PharmD, PhD, MD, DVM, or MSc in Biology/Life Science) preferred.
• At least 6 years of relevant pharmaceutical/biotechnology experience, including at least 4 years in Regulatory Affairs (regional/global) in early and late-stage development of multiple modalities; regulatory CMC experience not directly applicable.
• 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 preferred.
• Project leadership experience preferred.

Skills

• Regulatory strategy development
• HA engagement and briefing
• Global dossier preparation and submissions
• Cross-functional collaboration
• Regulatory submissions planning and tracking

Education

• BS/BA in a relevant scientific discipline; advanced degree preferred.