Regulatory Strategist

Role Summary

Regulatory Strategist collaborates with the Global Regulatory Team to define and drive the global regulatory strategy for assigned projects, including US, EU, and/or global regulatory activities and Health Authority interactions. The role provides regulatory guidance on procedural and documentation requirements to cross-functional teams, ensuring alignment with business objectives and timely delivery.

Responsibilities

• Enables the Global Regulatory Lead by providing quality regulatory input and position to internal partners, including clinical development teams, 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 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 for projects in their remit, as needed.
• Develops HA engagement and interaction plans, including authoring briefing documents, guiding meeting preparations, and moderating meetings for projects in their remit.
• May lead HA meetings and preparations; leads submission teams to ensure NDA/BLA/MAA/Extensions filings meet timelines for product launch and develops/updates the core global dossier (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, including submission content plans, tracking, and document management with cross-functional or alliance partner input.

Qualifications

• Required: BS/BA degree in a relevant scientific discipline.
• Preferred: Advanced degree (PharmD, PhD, MD, DVM, or MSc in Biology, Life Science, or related field).
• Required: At least 6 years of relevant pharmaceutical/biotechnology experience, including at least 4 years of regulatory affairs experience (regional and global) in early and late-stage development across multiple modalities.
• Preferred: Demonstrated experience with preparation of (s)BLA/(s)NDA/MAA, INDs/CTAs, HA briefing documents, and negotiation with a national/regional HA.
• Preferred: Experience on multidisciplinary matrixed project teams (e.g., clinical study teams).
• Preferred: Project leadership experience.