Regulatory Operations Associate Director

Job Summary

Responsible for executing regulatory submissions in the US and internationally, the fully remote Regulatory Operations Associate Director will manage the Regulatory Information Management (RIM) system, collaborate with CRO partners, and oversee project management for regulatory timelines.

Key responsibilities

• Act as the RIM system owner for all regulatory submissions, ensuring compliance and managing vendor relationships
• Collaborate with CRO partners to facilitate global regulatory submissions and maintain project timelines
• Assist in developing and maintaining departmental processes, policies, and standard operating procedures (SOPs)

Required qualifications

• 7+ years of experience in a biotech or pharmaceutical research environment, with 5+ years in Regulatory Affairs Operations
• Bachelor's degree in a scientific discipline
• Experience managing RIM systems and health authority electronic portals, with VEEVA experience preferred
• Background in supporting oncology drug development programs from a Regulatory Operations perspective
• Strong collaboration skills to work effectively with multiple stakeholders, including external CROs