Director, Regulatory Affairs - Gene Therapy

Role Summary

The Director, Regulatory Affairs will serve as the regulatory leader on cross-functional teams, guiding strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in alignment with Insmed’s business needs.

Responsibilities

• Independently serving as the regulatory representative on cross functional teams
• Communicating regulatory strategies and risk assessments to cross-functional teams and senior leadership, as needed
• Collaborate with Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program Management, and external consultants to align regulatory results and ensure strategic integration of regulatory considerations into program plans
• Independently lead the central messaging, preparation, and submission of high quality, regulatory compliant regulatory dossiers
• Direct hands-on experience with key regulatory dossiers including, but not limited to, meeting requests, briefing documents, Orphan drug applications, INDs, CTAs, CTNs, and applications for expedited pathways (fast track, RMAT, etc.)
• Proactively communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teams
• With oversight from the VP of Regulatory Affairs, lead the development and implementation of global regulatory strategy plans to facilitate efficient and driven product development
• Monitor the evolving regulatory competitive landscape to identify potential opportunities and areas of risk to assigned programs
• Provide strategic regulatory guidance and input in problem solving and issue resolution
• Develop risk mitigation plans for key partners
• Provide regulatory review of documentation prepared by other technical functions supporting product development activities (e.g., clinical protocols, clinical study reports, statistical analysis plans, etc.) in accordance with regulatory guidelines/requirements
• Provide leadership and management for the coordination and preparation of submissions consistent with regulatory requirements and in accordance with corporate strategy and timelines
• Ensure accuracy and consistency of regulatory submissions and correspondence; handle vendor/consultant roles where applicable
• Represent regulatory affairs in interactions with Health Authorities
• Serve as the regulatory point of contact for interactions with FDA and other global health authorities
• Assist/Lead communications with FDA and with other Health Authorities (such as EMA and PMDA)
• Support and monitor the development of new/revised regulatory requirements or procedures and communicate their potential impact to key collaborators
• Mentor junior regulatory professionals and support a culture of continuous learning, cross-training, and operational excellence
• In partnership with Regulatory Operations and/or third-party service providers, ensure high quality, on-time submission activities related to regulatory file maintenance e.g. IND/CTA, information amendments, SAE reports

Qualifications

• Bachelor’s degree in scientific field; advanced degree in a scientific or regulatory area (Master's/PhD/PharmD) preferred; RAC certification desired
• 10+ years of experience in Regulatory Affairs and product development in pharma/biotech; 5+ years of gene therapy orphan (rare) drug development experience preferred
• Knowledge or experience of neurology and/or ophthalmology drug development
• Experience with IND/CTA submissions and global registration applications (e.g., NDA, NDS and MAA)
• Prior experience leading direct interactions with Health Authorities
• Prior regulatory leadership within gene therapy or orphan (rare) diseases
• Prior experience serving as the regulatory lead on cross-functional teams (CMC, clinical and project teams)
• Ability and experience in development and execution of global regulatory strategy
• In-depth knowledge of US/EU/Japan/International regulations, guidance documents and ICH guidance
• Regulatory writing/review experience supporting product development and clinical trials
• Solid understanding of electronic submissions (eCTD)
• Strong collaboration across multiple functional areas; proven cross-functional leadership
• Excellent written and verbal communication skills, including regulatory writing
• Highly organized with strong attention to detail, clarity, accuracy, and conciseness

Skills

• Regulatory strategy development
• Regulatory writing and document review
• Cross-functional leadership
• Health Authority engagement
• Global submissions management
• Risk assessment and mitigation
• Strategic problem solving
• Regulatory intelligence and landscape monitoring

Education

• Bachelor’s degree in scientific field; advanced degree preferred