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.