Regulatory Strategist

Role Summary

Regulatory Strategist in Cambridge, MA. Responsible for contributing to global regulatory strategy and leading regulatory efforts across US, EU, and/or global channels for assigned projects, including Health Authority interactions. Provides regulatory expertise to cross-functional teams to support development and lifecycle management of drug products.

Responsibilities

• Enables the GRL by providing quality regulatory input and position to internal business partners, including clinical development teams, commercial and Global Regulatory Team for assigned projects
• Liaises with clinical, commercial, and other internal business partners in partnership with the GRL to enable successful regulatory outcomes
• Contributes to the development of a harmonized regulatory voice through participation in appropriate committees and forums at the direction of the GRL
• Contributes to the GRT for assigned projects with strategic input on TPP, business planning, governance, and committees; may lead GRT meetings
• Represents GRT strategic position at regulatory forums/committees as requested
• May serve as regional/local regulatory lead and point of contact with Health Authorities for projects/products in remit
• Identifies regulatory risks and proposes mitigations with GRL collaboration
• Contributes to Global Regulatory Project Strategy (GRPS) and ensures alignment with core product labeling
• Develops and monitors global regulatory environment; updates standards and processes related to drug/biologics regulations
• Ensures regulatory team members have information to contribute to Global Regulatory Strategy
• May contribute to global HA interaction strategy; attends HA meetings and communicates outcomes to management
• May lead Health Authority meetings and preparations as designated
• Leads submission team or regulatory subteam to meet NDA/BLA/MAA/Extensions timelines; develops and updates core global dossier; collaborates with regional lead for region-specific submissions
• Leads IND/CTA submission strategy to meet timelines for clinical trial initiation
• Ensures regulatory messaging is aligned with program and company objectives
• Contributes to content and reviews regulated documents (IB, PBRER, DSUR, RMP, etc)
• Accountable for Health Authority engagement plans, including authoring briefing documents and leading team through meeting preparations
• Supports operational and compliance activities for assigned deliverables; develops submission plans, tracking, and document management
• Communicates with relevant Health Authorities accurately and in a timely manner

Qualifications

• Must be currently enrolled in 2024-2026 Sanofi PharmD Fellows Program.
• BS/BA in a relevant science, or MSc in Biology/Life Science, with at least 5 years of pharma/biotech experience including at least 3 years in Regulatory Affairs, or advanced degree (PharmD, PhD, MD, DVM) with at least 2 years of regulatory/pharma experience.

Knowledge, Skills & Competencies

• Curiosity and openness to diverse perspectives
• Understanding of clinical development of drugs and/or novel biologics
• Business acumen, leadership, influencing and negotiation skills
• Strong oral and written communication skills
• Experience with electronic document management systems (e.g., Veeva Vault) a plus
• Ability to manage multiple projects simultaneously
• Sensitivity to multicultural/multinational environments

Education

• As listed in Qualifications