Associate Director, Regulatory Affairs Project Management

Insmed Incorporated is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. They are seeking an Associate Director for Regulatory Affairs Project Management to manage complex regulatory submissions and ensure compliance with regulatory authority regulations and guidelines.

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
• 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 and manage 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
• 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

Requirements:

• 7+ years of experience in regulatory affairs
• In-depth knowledge of global regulatory submission requirements, processes and procedures, eCTD structure/format, associated Insmed systems and planning software
• 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
• 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
• Proven project management, organizational and time management skills to manage multiple ongoing projects simultaneously
• Bachelor's Degree (in life sciences or chemistry preferred)
• 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