Senior Manager, Regulatory Affairs

📋 Description

• Lead regulatory activities across clinical, non-clinical, and CMC for development projects.
• Develop regulatory strategies to accelerate approvals and clearances.
• Manage regulatory dossiers for INDs, BLAs/NDAs, amendments, and submissions (US and international).
• Prepare and submit regulatory documents and briefing packages.
• Represent Regulatory Affairs on cross-functional teams for development goals.
• Maintain submissions and archives per requirements and procedures.

🎯 Requirements

• Bachelor’s degree; 7+ years in regulatory affairs; equivalent experience considered.
• Experience preparing and managing IND submissions; NDA experience preferred.
• Strong CTD/eCTD knowledge; proficiency with Adobe Acrobat or similar tools.
• Working knowledge of FDA regs and ICH; experience with other regions a plus.
• Solid GMP, GLP, GCP understanding and product development lifecycle.
• Ability to coordinate complex, cross-functional regulatory projects.

🎁 Benefits

• Annual base salary: $139,800–$184,800; final compensation based on factors like experience and
• Eligibility for annual bonus plan; equity awards; Employee Stock Purchase Plan.
• Comprehensive medical, dental, and vision insurance.
• 401(k) retirement plan; FSA/HSA options.
• Life insurance coverage; paid time off and wellness programs.
• Remote work arrangement within the United States.