Associate Director, Regulatory Affairs Project Management

About the role

We're seeking an Associate Director, Regulatory Affairs Project Management to join our growing Regulatory Affairs team. Reporting to the Director, Regulatory Affairs Project Management, you'll play a crucial role in supporting global submission teams.

Responsibilities

• Lead submission planning discussions with the Regulatory team, ensuring alignment on roles and responsibilities, and assessing potential risks and impacts.
• Create and maintain a Global Submission Plan, detailing dossier content, key activities, and timelines, and anticipate approval dates.
• Coordinate post-submission activities, such as FDA Advisory Committee meetings, mock rehearsals, and Oral Explanation meetings.
• Utilize in-depth knowledge of global regulatory submission requirements, processes, and procedures, as well as eCTD structure/format, to ensure timely and compliant submissions.
• Manage submission documents/components for simultaneous global regulatory submissions in eCTD format, ensuring timely delivery and coordination with the publishing team.
• Adhere to and advise others on global Regulatory Authority regulations and guidance, differing across regions and authorities.

Requirements

• 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 gene therapy
• 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
• Strong organizational and time management skills
• Ability to lead in a matrix environment and ensure cross-functional team objectives are met
• Hands-on experience coordinating and managing simultaneous global regulatory submission projects in eCTD format

Skills

• In-depth knowledge of global regulatory submission requirements and processes
• Experience with eCTD structure/format and associated Insmed systems and planning software
• Proven project management, organizational, and time management skills
• Ability to track and coordinate submission components, including internal reviews and approvals
• Knowledge of global Regulatory Authority regulations and guidance

Benefits

At Insmed, you'll enjoy comprehensive medical, dental, and vision coverage, mental health support, and generous paid time off policies. We offer fertility and family-forming benefits, caregiver support, flexible work schedules, and more. Join us to transform the lives of patients with serious diseases.

Pay

$164,000.00 - $213,000.00 Annual