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Insmed is a global biopharmaceutical company dedicated to creating life-transforming therapies for patients with serious and rare diseases that have limited tre
Senior Director, Regulatory Affairs – Gene Therapy
Location
United States
Posted
107 days ago
Salary
$222K - $303K / year
No structured requirement data.
Job Description
Senior Director, Regulatory Affairs – Gene Therapy
Insmed
At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: We’re looking for a Senior Director on the Regulatory Affairs, Gene Therapy team to help us expand what’s possible for patients with serious diseases. Reporting to the VP, Regulatory Affairs, Gene Therapy you’ll serve as the regulatory lead at the Global Project Team (GPT) for assigned program(s). You may also serve as the regulatory lead at the sub team level, as needed, to support business needs. This role can be onsite, hybrid or remote. What You'll Do: In this role, in collaboration with the VP and program lead, you’ll have the opportunity to define, develop, and implement a well-defined global regulatory strategy plan to facilitate efficient and competitive product development from early to late-stage development through registration and life-cycle management. You’ll also: - Provide expert analysis and strategic guidance on regulatory risks, pathways, and policy shifts to ensure program objectives are met - Actively participate in cross-functional decision-making discussions to ensure potential regulatory impact on product development and lifecycle management are communicated and considered - Proactively identify and communicate potential risks and define mitigation strategy to prevent, or minimize, their impact to assigned program(s) - Lead overall strategy and preparation of key regulatory dossiers including, but not limited to, meeting requests, briefing documents, Orphan drug applications, INDs, CTA/CTRs, CTNs, and applications for expedited pathways (fast track, RMAT, etc.) as needed - Lead monthly Global Regulatory Team meeting - Present regulatory strategy at cross-functional team meetings and to senior leadership, upon request - Monitor the evolving regulatory competitive landscape to identify potential opportunities and areas of risk to assigned programs - Interpret complex regulatory regulations/guidance’s to inform development plans and potential impact to key stakeholders - In concert with the regulatory policy lead, influence regulatory environment via commenting on draft guidance’s of direct interest to Insmed’s gene therapy portfolio - Regulatory technical writing and review of documentation prepared by other technical functions (nonclinical, clinical and CMC) 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 accurate archiving of correspondence and submissions, and manage vendor/consultant roles, where applicable. - Serve as the primary contact with FDA, guide and/or lead complex interactions with regulatory and health agencies (e.g., FDA) on critical regulatory matters - Mentor junior regulatory professionals and support a culture of continuous learning, cross-training, and operational excellence. - In partnership with assigned regulatory lead and regulatory operations, and/or third-party service providers, ensure high quality, complaint, on-time submission activities related to initial regulatory filings and application maintenance e.g., IND/CTA/CTR, information amendments, SAE reports, etc.) Who You Are: You have a Bachelor’s degree along with 12 years of experience in Regulatory Affairs, and/or relevant product development experience in the pharmaceutical or biotechnology industry. You are or you also have: - 5+ years of gene therapy orphan (rare) drug development experience - Strong leader and strategic thinker with prior experience in the development and execution of global drug development of gene therapies for orphan (rare) diseases ideally in both early and late phase development - Prior experience serving as a Global regulatory lead on a multi-functional cross functional development team - Proven ability to influence/inform cross functional teams on potential regulatory risks of strategic decisions and provide sound regulatory guidance to ensure program and company objectives are met - Experience in partnering with Regional regulatory leads to ensure local regulatory planning and strategy aligns and supports the Global development strategy - In-depth knowledge and direct application of US/EU/Japan/International regulations and ICH guidance documents pertaining to gene therapy product development - Strong working knowledge and experience with electronic submissions (eCTD) - Experienced in the submission and management of IND/CTA/CTRs and global registration applications (e.g., BLA, J-NDA, and MAA); post approval life cycle management - Experience in leading direct interactions with Health Authorities at key milestone meetings and on complex regulatory matters - Strong team player with ability to effectively collaborate across multiple functional areas - Proven ability to manage multiple priorities simultaneously in a fast-paced, growing organization - Excellent communication skills (verbal and written) - Strong attention to detail, clarity, accuracy, and conciseness Nice to have (but not required): - Master's/PhD/PharmD - RAC certification - Knowledge of neurology and/or ophthalmology drug development and regulation of medical devices Where You’ll Work This role can either be onsite, hybrid or remote. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected. Travel Requirements This role requires occasional travel (approximately 25%) #LI-REMOTE #LI-MC1 Pay Range: $222,000.00-303,000.00 Annual Life at Insmed At Insmed, you’ll find a culture as human as our mission—intentionally 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. Current Insmed Employees: Please apply via the Jobs Hub in Workday. Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled.
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