Regulatory Strategist

Role Summary

Regulatory Strategist serves as a key member of the Global Regulatory Team, partnering with the Global Regulatory Lead to define and execute aligned regulatory strategies for US, EU, and global programs, including Health Authority interactions. The role provides regulatory expertise on procedural and documentation requirements to cross-functional teams to ensure delivery of business objectives. Location: Cambridge, MA or Morristown, NJ.

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 of products.
• 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 the team through meeting preparations and moderating meetings.
• 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 and develops/updates the core global dossier, collaborating with regional leads where region-specific submissions apply.
• 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 submission content plans, submission tracking, and document management with cross-functional teams and alliance partners where relevant.

Qualifications

About You

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