Insmed
Director, Regulatory Affairs - Gene Therapy
Insmed, San Diego, California, United States, 92101
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. 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.) 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 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 Salary Range
$179,000 - $250,800 a year Compensation & Benefits
At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location: Flexible approach to how we work Health benefits and time-off plans Competitive compensation package, including bonus Equity Awards (Long-Term Incentives) Employee Stock Purchase Plan (ESPP) Additional Information
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. 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.
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. 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.) 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 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 Salary Range
$179,000 - $250,800 a year Compensation & Benefits
At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location: Flexible approach to how we work Health benefits and time-off plans Competitive compensation package, including bonus Equity Awards (Long-Term Incentives) Employee Stock Purchase Plan (ESPP) Additional Information
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. 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.