Associate Director, Regulatory Affairs Project Management (Biotech)

TL;DR

Associate Director, Regulatory Affairs Project Management (Biotech): Managing complex global regulatory submissions for serious and rare disease therapies with an accent on submission planning, cross-functional coordination, and compliance with global regulatory standards. Focus on driving aggressive submission timelines, mitigating risks in the eCTD process, and leading matrixed teams through the full lifecycle of marketing applications.

Location: Must be based in the U.S. (Fully remote role with occasional travel required).

Salary: $164,000–$213,000 Annual

Company

A global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.

What you will do

• Lead submission planning discussions and align cross-functional teams on roles, responsibilities, and deliverables.
• Create and maintain Global Submission Plans, tracking content, activities, and timelines for global marketing applications.
• Coordinate post-submission activities including FDA Advisory Committee meetings and Oral Explanation meetings.
• Ensure compliance with global regulatory requirements, eCTD structures, and internal operating procedures.
• Proactively manage critical path analysis and identify risks to avoid delays in submission dates.
• Track delivery of submission components and coordinate with publishing teams for timely filing.

Requirements

• Must be based in the U.S.
• Bachelor’s degree in life sciences or chemistry preferred.
• 7+ years of experience in regulatory affairs within the pharmaceutical industry.
• Proven project management experience, preferably in the Gene Therapy space.
• Expertise with Smartsheet, Veeva Vault RIM, and Microsoft Office.
• Experience with global regulatory submissions (FDA, EMA, MHRA, PMDA) from pre-IND through Phases I-IV.

Nice to have

• Experience with AI-driven tools for regulatory documentation or submission analysis.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage with mental health support.
• 401(k) plan with company match and annual equity awards.
• Generous paid time off and flexible work schedules.
• Access to the Company Learning Institute, LinkedIn Learning, and mentorship programs.
• Employee resource groups and service programs.