Regulatory Strategist

Role Summary

Regulatory Strategist located in Cambridge, MA or Morristown, NJ. The role is a key member of the Global Regulatory Team responsible for defining the global regulatory strategy and enabling the execution of aligned US, EU, and/or global regulatory strategies for assigned projects, including Health Authority interactions.

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 as well as lifecycle management.
• May serve as regional/local regulatory lead and point of contact with Health Authorities for projects/products in their remit, as needed.
• Accountable for developing Health Authority engagement and interaction plans for assigned products, including authoring briefing documents focused on strategy and scientific content, leading team through meeting preparations, and moderating meetings.
• May lead HA meetings and preparations as designated. Leads submission team or regulatory sub-team to ensure NDA/BLA/MAA/Extensions filings meet project timelines for product launch and develops and updates the core global dossier, collaborating with regional leads on region-specific submissions.
• Leads the 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 generating submission content plans, submission tracking, and document management with cross-functional teams and/or alliance partners where relevant.

Qualifications

• Required: BS/BA degree 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 of regulatory affairs experience (regional and global) in early and late-stage development of multiple modalities; experience within 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 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.