Regulatory Strategist

Role Summary

The Regulatory Strategist partners with the Global Regulatory Lead to define and drive global regulatory strategy for assigned projects, including Health Authority interactions, and to guide cross-functional teams across regions to ensure delivery of business objectives.

Responsibilities

• Enables the GRL by providing quality regulatory input and position to internal business partners, including clinical development teams, commercial, and GRT for assigned projects.
• Contributes to the GRT for assigned projects with strategic 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/products in scope.
• Develops HA engagement and interaction plans, authors briefing documents, leads meeting preparations, and moderates meetings for projects in scope.
• May lead 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, collaborating with regional leads for region-specific submissions.
• Leads IND/CTA submission strategy to align with project timelines for clinical trial initiation.
• Supports operational and compliance activities, develops and executes regulatory submission planning, content plans, submission tracking, and document management with cross-functional and alliance partners as relevant.

Qualifications

About You

• Required: BS/BA 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 pharmaceutical/biotechnology experience, including at least 4 years in Regulatory Affairs (regional and global), across early and late-stage development of multiple modalities.
• Preferred: Experience with preparation of (s)BLA/(s)NDA/MAA, INDs/CTAs, HA briefing documents, and negotiating with national/regional HAs.
• Preferred: Experience on multidisciplinary matrixed project teams (e.g., clinical study teams).
• Preferred: Project leadership experience.

Education

• BS/BA required; advanced degree preferred as listed above.