Associate Director, Regulatory Affairs Project Management

Insmed Incorporated

1d • $164,000 - $213,000 • Remote

About The Position

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.

Requirements

• You have a Bachelor’s Degree (in life sciences or chemistry preferred) along with 7+ years of experience in regulatory affairs.
• Project management experience in the pharmaceutical industry or in a regulatory environment, 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

Responsibilities

• 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.
• 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level