Senior Manager, Clinical Regulatory Affairs

📋 Description

• Support the development and implementation of global clinical regulatory strategies for assigned
• Prepare, review, and support submission of regulatory documents, including INDs, CTAs, protocol
• Partner with clinical development, clinical operations, medical writing, pharmacovigilance, CMC
• Support planning and preparation for FDA, EMA, national competent authority, and other global
• Provide regulatory input into clinical study designs, protocols, investigator brochures, informed
• Monitor regulatory requirements, guidance, precedents, and competitive intelligence relevant to

🎯 Requirements

• Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or a related discipline required
• For Senior Manager level, 5+ years of relevant Regulatory Affairs experience.
• For Associate Director level, 8+ years of demonstrated experience supporting clinical-stage drug
• Hands-on experience with FDA submissions and interactions, including INDs, protocol amendments
• Experience supporting EU and broader global clinical trial applications and health authority
• Working knowledge of ICH guidelines, FDA regulations, EU Clinical Trials Regulation requirements

🎁 Benefits

• Senior Manager base salary: $159,800–$197,400 annually.
• Associate Director base salary: $164,500–$202,650 annually.
• Competitive medical, dental, and vision insurance plans.
• 401(k) plan through Fidelity with a 100% company match on the first 4% of employee deferrals.
• Generous paid time off policy.
• Employee commuter benefits.