Regulatory Strategist

Role Summary

Regulatory Strategist, located in Cambridge, MA or Morristown, NJ. As 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 define the global regulatory strategy and enable the execution of aligned US, EU, and global regulatory strategies for assigned projects, including Health Authority interactions. The RS provides regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams to ensure the delivery of business objectives.

Responsibilities

• Enables the GRL by providing quality regulatory input and position to internal business partners, including but not limited to the 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 for providing strategic input on the Target Product Profile (TPP), business planning, governance and committees. May be requested to 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 for 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.
• Accountable for developing the HA engagement and interaction plans for their assigned products, including the authoring of the briefing document focused on the strategy and scientific content, leading the team through meeting preparations and moderating the meeting itself for the projects in their remit.
• May lead HA meetings and preparations as designated. Leads submission team or regulatory sub-team to ensure NDA/BLA/MAA/Extensions filings meet the project timelines for product launch and is responsible for the development and update of the core global dossier, collaborating with regional lead where region-specific submissions are applicable.
• Leads the IND/CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiation.
• Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, and document management utilizing the support and input of cross-functional team and/or alliance partners where relevant.

Qualifications

• Required: BS/BA degree in a relevant scientific discipline. Advanced degree (PharmD, PhD, MD, or 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 relevant Regulatory Affairs experience (regional and global), in early and late-stage development of multiple modalities; experience within regulatory CMC not directly applicable.
• Preferred: 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.