Insmed
Director, Regulatory Affairs - Gene Therapy
Insmed, San Diego, California, United States, 92189
Director, Regulatory Affairs
The Director, Regulatory Affairs will serve as the regulatory leader on cross-functional teams, where they will be responsible for 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. What You'll Do: 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 complaint 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, etc. 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, etc.) Who You Are: 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 experience within the pharmaceutical or biotechnology industry, preferably with 5+ years of gene therapy orphan (rare) drug development experience 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 experience in 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 the development and execution of Global regulatory strategy In-depth knowledge and direct application of US/EU/Japan/International regulations, regional guidance documents and ICH guidance documents Regulatory writing and/or review of documents supporting product development and clinical trials Solid understanding and experience with electronic submissions (eCTD) Strong teammate with the ability to collaborate effectively across multiple functional areas Shown ability to lead cross-functional initiatives and build effective partnerships Handle multiple priorities in a fast-paced, growing organization Exceptional written and verbal communication skills, including regulatory writing Highly organized with a strong attention to detail, clarity, accuracy, and conciseness Pay Range: $179,000.00-250,800.00 Annual Life at Insmed At Insmed, you'll find a culture as human as our missionintentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself. Highlights of our U.S. offerings include: Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP) Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.
The Director, Regulatory Affairs will serve as the regulatory leader on cross-functional teams, where they will be responsible for 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. What You'll Do: 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 complaint 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, etc. 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, etc.) Who You Are: 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 experience within the pharmaceutical or biotechnology industry, preferably with 5+ years of gene therapy orphan (rare) drug development experience 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 experience in 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 the development and execution of Global regulatory strategy In-depth knowledge and direct application of US/EU/Japan/International regulations, regional guidance documents and ICH guidance documents Regulatory writing and/or review of documents supporting product development and clinical trials Solid understanding and experience with electronic submissions (eCTD) Strong teammate with the ability to collaborate effectively across multiple functional areas Shown ability to lead cross-functional initiatives and build effective partnerships Handle multiple priorities in a fast-paced, growing organization Exceptional written and verbal communication skills, including regulatory writing Highly organized with a strong attention to detail, clarity, accuracy, and conciseness Pay Range: $179,000.00-250,800.00 Annual Life at Insmed At Insmed, you'll find a culture as human as our missionintentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself. Highlights of our U.S. offerings include: Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP) Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.