Regulatory Strategy Manager

Role Summary

Regulatory Strategy Manager will drive regulatory strategy and submissions for gene therapy programs, lead agency interactions, and ensure alignment across US, EU, and global trials. Based at Solid Biosciences in Charlestown, MA with hybrid work expectations (2–3 days in office). The role collaborates with cross-functional teams on development strategies and regulatory intelligence.

• Actively represents Regulatory on interdisciplinary teams (e.g., Clinical Study Teams)
• Support US, EU, and global clinical trials including the preparation of initial INDs/CTAs/GMOs and amendments, responses to agency questions, and maintenance activities
• Support development and implementation of regulatory strategies to facilitate the progress of programs through all phases of development
• Offer submission strategies for development products and identifies potential regulatory risks
• Collaborate with cross-functional teams to generate and refine the product development strategy
• Responsible for coordinating and driving regulatory submissions, including necessary cross functional teams and timelines, relevant to assigned projects or programs
• Actively contribute to the preparation and execution of agency meetings
• Act as regulatory representative at meetings with business partners such as CROs, consultants, etc.
• Act as resource for team on evolving regulatory requirements, regulatory precedents, and intelligence
• Ability to work both independently and within project teams, committees, etc. to achieve group goals
• Represent Solid Bio Regulatory through participation in pharmaceutical trade groups and meetings
• Actively monitor regulatory policy and intelligence and disseminate information to teams

• Bachelor’s degree in a scientific discipline;
  Masters, Pharm
  
  D, or PhD preferred. Minimum of 2 years of experience in regulatory affairs in the pharmaceutical/biotech, including IND activity, global CTAs, DSURs and Agency briefing documents in US and ex-US
• Experience in gene therapy programs and/or rare disease a plus, although not required
• Strong knowledge of US and EU regulations and Guidances pertaining to the conduct of investigational drug studies
• Ability to effectively organize and prioritize tasks to achieve established deadlines
• Excellent verbal and written communication skills
• Excellent organizational and program management skills that ensure timely completion of objectives by appropriate prioritization, scheduling and assignment of tasks
• Strong collaborator with multi-disciplinary teams
• Creative problem solving and strategizing abilities

• Bachelor’s degree in a scientific discipline;
  Masters, Pharm
  
  D, or PhD preferred

• Regulatory strategy development
• IND/CTA/GMOs submissions and regulatory correspondence
• Cross-functional collaboration and program management
• Regulatory intelligence and policy monitoring
• Excellent communication (oral and written) and presentation skills