Associate Director, Regulatory Affairs

This role will provide business-aligned guidance focused on governance, compliance, and operational risk management. You will partner with leaders, compliance stakeholders, and cross-functional teams to translate complex issues into practical recommendations, strengthening responsible execution, improving decision-making, and supporting sustainable growth within a life sciences environment.

Location: Remote - US based candidates only, no visa sponsorship available

Responsibilities

• Lead planning and execution of global regulatory activities for clinical trials
• Develop and execute global regulatory strategies for clinical trial submissions
• Provide regulatory guidance on country-specific submission requirements
• Assess regulatory impact of protocol amendments and determine classifications
• Ensure alignment of submission strategies with local regulatory expectations
• Oversee submission timelines to meet clinical development milestones
• Ensure submission packages are scientifically sound and compliant

Qualifications

• Bachelor's degree required; advanced degrees preferred (PhD, PharmD, MD, MS)
• 5+ years of Regulatory Affairs experience in pharmaceuticals or biotechnology
• Direct experience with global clinical trial authorizations (CTAs, CTNs, INDs)
• Excellent organizational and planning skills, able to meet tight deadlines
• Strong interpersonal skills for cross-functional collaboration
• Proficient in MS Office Suite, Adobe Acrobat, and Veeva Vault

Benefits

• Comprehensive medical, dental, and vision coverage
• Annual wellbeing reimbursement and mental health support
• Generous paid time off and family-forming benefits
• 401(k) plan with competitive match and annual equity awards
• Access to the Company Learning Institute and skill-building resources
• Opportunities for volunteerism and community engagement

Pay

$164,000 – $213,000 annually