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Insmed Incorporated · 3 days ago

Director, Regulatory Affairs - Gene Therapy

San Diego, CA

Full-time

Hybrid

Director/Executive

$179K/yr - $251K/yr

10+ years exp

Insmed Incorporated is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. The Director, Regulatory Affairs will serve as the regulatory leader on cross-functional teams, guiding strategy and ensuring global regulatory compliance for assigned programs.

BiotechnologyMedicalPharmaceutical

Growth Opportunities

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 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.)

Qualification

Regulatory AffairsGene TherapyIND/CTA submissionsGlobal regulatory strategyRegulatory writingNeurologyOphthalmologyCross-functional leadershipCommunication skillsAttention to detailTeam collaboration

Required

Bachelor's degree in scientific field

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

Preferred

Advanced degree in a scientific or regulatory area (Master's/PhD/PharmD) preferred

RAC certification desired

Benefits

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

Company

Insmed Incorporated

Insmed is a people-ﬁrst global biopharmaceutical company striving to deliver ﬁrst- and best-in-class therapies to transform the lives of patients facing serious diseases.

Founded in 1988

Bridgewater, New Jersey, USA

1001-5000 employees