Associate Director, Regulatory Affairs Project Management

Role Summary

Associate Director, Regulatory Affairs Project Management on the Regulatory Affairs team to help 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 plan and manage complex regulatory submissions (including global marketing applications, product line extensions, and supplements) from submission preparation to approval, ensuring that dossiers are prepared in a timely manner and in compliance with Regulatory Authority regulations and Insmed Operating Procedures. This is a fully remote role with occasional travel for team meetings or events.

Responsibilities

• 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.
• 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
• Coordinate 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 coordinate submission publishing activities with the publishing team
• Understand, adhere to, and advise 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

Qualifications

• Project management experience in the pharmaceutical industry or in a regulatory environment, with expertise in 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

Skills

• Regulatory planning and submission management
• Cross-functional collaboration and stakeholder management
• Knowledge of global regulatory submission requirements (including eCTD)
• Strong analytical and problem-solving abilities

Education

• Bachelor’s Degree (in life sciences or chemistry preferred)

Additional Requirements

• Travel: Minimal travel required (occasional travel for team meetings or events may be expected)