Associate Director, Regulatory Affairs Project Management

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 an Associate Director, Regulatory Affairs Project Management on the Regulatory Affairs team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Regulatory Affairs Project management, you’ll work with global submission teams to project, manage complex regulatory submissions (including global marketing applications, product line extensions, and supplements) from submission preparation to approval, ensuring that applications and dossiers are prepared in a timely manner and in compliance with Regulatory Authority regulations and guidance’s and Insmed Operating procedures. What You'll Do: In this role, you’ll have the opportunity to lead submission planning discussions with close collaboration with Regulatory team, ensure submission team is aware of upcoming deliverables, align on roles and responsibilities, understand the interdependence between submission activities and components, and that any issues, risks, or impact due to changes in strategy and/or timelines are assessed quickly throughout the submission process. You’ll also: In collaboration with contributing functional lines, create and maintain a Global Submission Plan that captures detailed list of dossier content, key activities and timelines associated with delivery of the submission and associated anticipated approval dates Work with Regulatory team to coordinate post initial submission activities in support of approval process, such as FDA Advisory Committee meetings, mock rehearsals, Oral Explanation meetings etc. Have and be able to utilize in-depth knowledge of global regulatory submission requirements, processes and procedures, eCTD structure/format, associated Insmed systems and planning software to ensure teams meet aggressive target submission dates by proactively focusing on critical path analysis, hand offs, scenarios, and reducing "rework" to avoid costly time delays Have hands-on experience coordinating and managing submission documents/components for simultaneous global regulatory submission projects in eCTD format [e.g., NDA/BLA/INDs, MAAs, JNDAs, etc.] Track timely delivery of submission components, including internal review and approvals and coordinates submission publishing activities with publishing team. Be responsible for understanding, adhering to, and advising others on global Regulatory Authority regulations and guidance associated with electronic submissions, which differ across regions and Regulatory Authorities Possess proven project management, organizational and time management skills to manage multiple ongoing projects simultaneously Who You Are: You have a Bachelor’s Degree (in life sciences or chemistry preferred) along with 7+ years of experience in regulatory affairs. You are or you also have: Project management experience in the pharmaceutical industry (preferably in the Gene Therapy space) and expertise with Smartsheet and/or other project management tools Regulatory experience from pre-IND through Phases I-IV for FDA, EMA, MHRA and PMDA. Excellent written and verbal communication skills and ability to present information in a clear and concise manner Excellent organizational skills, attention to detail and commitment to deliver high quality output Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams Software requirements: Veeva Vault RIM, Smartsheet, Microsoft Office Where You’ll Work This is a fully remote role. 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 15%) Pay Range: $164,000.00-213,000.00 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 View email address on click.appcast.io 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. For New York City Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool (“AEDT”) that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review. If you are an applicant for this role and a New York City resident, you have the right to request: A reasonable accommodation, if one is available under applicable law, by emailing View email address on click.appcast.io; and/or An alternative selection process by emailing View email address on click.appcast.io. Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at View email address on click.appcast.io. Insmed is a people-first global biopharmaceutical company driven to transforming the lives of patients with serious and rare diseases. Headquartered in Bridgewater, NJ, with locations across the U.S., EMEA, and Japan, we’re guided by our core values and a shared commitment to patients and each other. We’ve been named Science’s No. 1 Top Employer four years in a row, certified as a Great Place to Work in the U.S., and recognized among The Sunday Times’ and BioSpace’s Best Places to Work. For patients, each other, and the future of science, we’re in. Are you? Wherever you are in the world or in your career, we want to stay connected. Sign up for our talent community to hear about new career opportunities, company news, and how our teams around the world are striving to make a difference for patients every day. 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