Regulatory Strategist

Role Summary

Regulatory Strategist responsible for defining and executing global regulatory strategy across US, EU, and global projects, including Health Authority interactions, within a cross-functional team to drive alignment and business objectives.

Responsibilities

• Enables the Global Regulatory Lead 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 input on Target Product Profile, business planning, governance, and committees; may lead GRT meetings.
• Contributes to Global Regulatory Project Strategy and ensures alignment with product labeling for development and lifecycle management.
• Acts as regional/local regulatory lead and point of contact with Health Authorities as needed.
• Develops HA engagement and interaction plans, authors briefing documents, leads meeting preparations, and moderates meetings for projects in remit.
• Leads HA meetings and preparations as designated.
• Leads submission teams to ensure NDA/BLA/MAA/Extensions filings meet timelines; develops and updates the core global dossier and collaborates with regional leads for region-specific submissions.
• Leads IND/CTA submission strategy to meet timelines for clinical trial initiation.
• Supports operational and compliance activities for assigned deliverables, develops and executes regulatory submission planning, and manages documents with cross-functional teams and alliance partners where relevant.

Qualifications

• BS/BA in a relevant scientific discipline; advanced degree preferred.
• At least 6 years in pharmaceutical/biotechnology with at least 4 years in Regulatory Affairs (regional/global) across early and late-stage development; knowledge of regulatory CMC 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 and execution
• Health Authority engagement and briefing document preparation
• Global regulatory submissions planning and management
• Cross-functional collaboration in clinical development and regulatory affairs
• Project leadership and team facilitation

Education

• Bachelor's degree in a relevant scientific discipline; advanced degree preferred (PharmD, PhD, MD, DVM, or MSc).

Additional Requirements

• Location: Morristown, NJ / Cambridge, MA