Regulatory Strategist

Role Summary

Regulatory Strategist responsible for defining global regulatory strategy and enabling execution of aligned US, EU, and/or global regulatory strategy for assigned projects, including Health Authority interactions. Supports Oncology therapeutic area with regulatory expertise and guidance to GRT and cross-functional teams.

Responsibilities

• Enables the GRL by providing regulatory input and position to internal partners across clinical development, commercial, and GRT for assigned projects.
• Contributes to the Global Regulatory Team's strategic input on Target Product Profile, business planning, governance, and committees; may lead GRT meetings.
• Contributes to Global Regulatory Project Strategy and alignment with core product labeling and lifecycle management.
• May serve as regional/local regulatory lead and HA contact as needed.
• Develops HA engagement plans, authors briefing documents, leads meeting preparations, and moderates meetings for assigned projects.
• Leads HA/indirect meetings as designated.
• Leads submission teams to ensure NDA/BLA/MAA/Extensions filings align with timelines; develops and updates core global dossier and coordinates with regional leads for region-specific submissions.
• Leads IND/CTA submission strategy to meet clinical trial initiation timelines.
• Supports operational and compliance activities, develops submission planning, content plans, tracking, and document management with cross-functional input.

Qualifications

About You

• BS/BA in a relevant scientific discipline required; advanced degree (PharmD, PhD, MD, DVM, or MSc) preferred.
• At least 6 years of pharmaceutical/biotechnology experience, including at least 4 years in Regulatory Affairs (regional and global) across early and late-stage development of multiple modalities; regulatory CMC experience not directly applicable.
• Experience with preparation of sBLA/sNDA/MAA, INDs/CTAs, HA briefing documents, and negotiating with national/regional HAs preferred.
• Experience on multidisciplinary matrixed project teams preferred.
• Project leadership experience preferred.

Skills

• Regulatory strategy development
• HA engagement and briefing document authoring
• Global dossier development and submission management
• Cross-functional collaboration and leadership
• Regulatory affairs for multiple modalities

Education

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

Additional Requirements

• Travel and in-person engagement as required for regulatory meetings or project needs.