Director, Regulatory Affairs Strategy

Responsibilities

• Develop and lead global regulatory strategies for Phase 2 and Phase 3 clinical development programs
• Provide regulatory guidance on clinical development plans and pivotal trial designs
• Evaluate regulatory risks and develop mitigation strategies
• Lead planning for major milestones including major regulatory meetings and marketing applications
• Prepare and oversee global regulatory submissions for INDs, CTAs, and marketing applications
• Collaborate with cross-functional teams to integrate regulatory considerations into development plans
• Monitor evolving global regulatory requirements and advise leadership accordingly

Qualifications

• Bachelor's degree in a scientific or related field required; advanced degree preferred (PhD, PharmD, MD, or MS)
• 10+ years of progressive regulatory affairs experience within the pharmaceutical, biotechnology, or life sciences industry
• Significant experience leading regulatory strategy for Phase 2 and Phase 3 development programs
• Demonstrated success managing interactions with FDA and other major global health authorities
• Experience in supporting or leading NDA, BLA, MAA, or equivalent marketing application submissions

Benefits

• Premium health insurance for employees and dependents
• Wellness and employee support programs
• Life insurance and disability coverage
• Retirement plans with employer match
• Generous paid time off