[Hiring] Associate Director, Regulatory Affairs Project Management @Insmed Incorporated

Role Description

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 from submission preparation to approval.

What You'll Do:

• Lead submission planning discussions with close collaboration with Regulatory team.
• Ensure submission team is aware of upcoming deliverables and align on roles and responsibilities.
• Understand the interdependence between submission activities and components.
• Assess any issues, risks, or impacts due to changes in strategy and/or timelines quickly throughout the submission process.
• Create and maintain a Global Submission Plan that captures detailed list of dossier content, key activities, and timelines.
• Coordinate post-initial submission activities in support of the approval process.
• Utilize in-depth knowledge of global regulatory submission requirements, processes, and procedures.
• Have hands-on experience coordinating and managing submission documents/components for simultaneous global regulatory submission projects in eCTD format.
• Track timely delivery of submission components, including internal review and approvals.
• Understand, adhere to, and advise others on global Regulatory Authority regulations and guidance.
• Possess proven project management, organizational, and time management skills to manage multiple ongoing projects simultaneously.

Qualifications

• Bachelor’s Degree (in life sciences or chemistry preferred).
• 7+ years of experience in regulatory affairs.
• Project management experience in the pharmaceutical industry (preferably in the Gene Therapy space).
• 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.
• Excellent organizational skills and attention to detail.
• Ability to lead in a matrix environment.
• Software requirements: Veeva Vault RIM, Smartsheet, Microsoft Office.

Requirements

• Ability to present information in a clear and concise manner.
• Commitment to deliver high-quality output.

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, and caregiver support.
• Flexible work schedules with purposeful in-person collaboration.
• 401(k) plan with a competitive company match and annual equity awards.
• Participation in our Employee Stock Purchase Plan (ESPP) and company-paid life and disability insurance.
• Company Learning Institute providing access to LinkedIn Learning and skill-building workshops.
• Employee resource groups, service and recognition programs, and opportunities to connect and volunteer.