Senior Manager, Regulatory Affairs

Job Summary

To support regulatory planning and execution for global Phase 3 clinical programs, the full-time Senior Manager, Regulatory Affairs will manage submission planning, document preparation, and CRO oversight while collaborating with cross-functional teams in a remote working environment.

Key Responsibilities:

• Support the development and implementation of regulatory strategies and maintain submission plans for assigned studies
• Prepare, review, and coordinate clinical trial applications and related submissions to global health authorities
• Manage regulatory activities performed by CROs and vendors, ensuring compliance with timelines and quality standards

Required Qualifications:

• Bachelor's degree with 5-7+ years of experience in pharmaceutical regulatory affairs; advanced degree is a plus
• Experience managing clinical regulatory submissions in the US, EU, and globally
• Strong knowledge of global pharmaceutical regulations, including FDA, EMA, and ICH requirements
• Proficient in regulatory/technical writing for clinical trial documents
• Familiarity with regulatory affairs software and document management systems