Regulatory Strategist

Role Summary

Regulatory Strategist based in Cambridge, MA or Morristown, NJ. A key member of the Global Regulatory Team (GRT) and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist leverages regulatory expertise to contribute to the global regulatory strategy and enable the execution of aligned US, EU, and/or global regulatory plans for assigned projects, including Health Authority interactions. Provides regulatory guidance on procedural and documentation requirements to GRT and cross-functional teams to ensure delivery of business objectives.

Responsibilities

• Enables the GRL by providing quality regulatory input and position to internal business partners, including but not limited to clinical development teams, commercial, and GRT for assigned projects.
• Contributes to the GRT for assigned projects in alignment with the team's one regulatory voice, providing strategic input on the Target Product Profile (TPP), business planning, governance, and committees. May lead GRT meetings.
• Contributes to the development of the Global Regulatory Project Strategy (GRPS) and ensures alignment with core product labeling for products in development and for lifecycle management.
• May serve as a regional/local regulatory lead and point of contact with Health Authorities for projects/products in their remit, as needed.
• Develops HA engagement and interaction plans for assigned products, including authoring briefing documents focused on strategy and scientific content, leading meetings, and moderating discussions for projects in their remit.
• May lead HA meetings and preparations as designated. Leads submission teams or regulatory sub-teams to ensure NDA/BLA/MAA/Extensions filings meet project timelines for product launch; responsible for core global dossier development and region-specific submissions where applicable.
• Leads IND/CTA submission strategy to ensure preparation timelines meet project timelines for clinical trial initiation.
• Supports operational and compliance activities for assigned deliverables, develops and executes regulatory submission planning activities, including submission content plans, submission tracking, and document management with cross-functional teams and alliance partners where relevant.

Qualifications

About You

• Required: BS/BA in a relevant scientific discipline. Advanced degree (PharmD, PhD, MD, DVM, or MSc in Biology, Life Science, or related field) preferred.
• Required: at least 6 years of relevant pharmaceutical/biotechnology experience, including at least 4 years in Regulatory Affairs (regional and global) in early and late stage development across multiple modalities; experience in regulatory CMC not directly applicable.
• Required: demonstrated experience with preparation of (s)BLA/(s)NDA/MAA, INDs/CTAs, HA meeting briefing documents and negotiating with a national/regional HA is preferred.
• Preferred: experience on multidisciplinary matrixed project teams (e.g., clinical study teams).
• Preferred: project leadership experience.

Education

• BS/BA in a relevant scientific discipline required; advanced degree preferred (PharmD, PhD, MD, DVM, or MSc).