Sr. Specialist, Regulatory Strategy

Responsibilities

• Prepare and coordinate regulatory submissions including INDs, clinical trial applications, and annual reports
• Conduct reviews and quality checks of clinical regulatory documents and submission materials
• Maintain logs, databases, and compliance tracking systems for regulatory information
• Serve as departmental contact for internal company projects and coordinate with cross-functional teams
• Review investigator packages and authorize drug shipments to clinical sites

Requirements

• Bachelor's degree with 4+ years relevant experience, or Master's with 2+ years, or JD/PharmD/PhD
• Strong familiarity with FDA regulations and ICH guidelines for drug development
• Thorough understanding of US regulatory knowledge and ex-US compliance requirements
• Demonstrated proficiency with regulatory document preparation and submission processes
• Strong project management, analytical, and problem-solving skills
• Excellent computer skills and detail orientation with ability to manage multiple deadlines
• Ability to interpret and apply company standards and regulatory guidance consistently

Compensation: $103,300–$141,000 base salary annually, plus 20% target bonus and equity eligibility