Senior Manager, Regulatory Affairs

Role Overview

• Manage the preparation, compilation, and submission of CTAs, including CTIS submissions and country-specific applications
• Ensure CTA packages include all required documents (e.g., protocol, IB, IMPD, ICFs) and meet regional and country-specific requirements
• Provide regulatory guidance on EU CTR, CTIS processes, and country-specific CTA requirements
• Manage health authority questions and sponsor responses to support timely approvals
• Support CTA maintenance activities, including substantial modifications, protocol amendments, IMPD updates, quality changes, annual updates, and notifications
• Track submission status and maintain inspection-ready documentation and regulatory archives
• Partner closely with Clinical Development and Clinical Operations to support global study start-up timelines
• Collaborate with CMC and Quality teams to ensure accurate and compliant IMPD and quality documentation
• Serve as a regulatory liaison across internal teams and external partners to ensure timely and compliant submissions across ex-U.S. markets

Requirements

• Bachelor’s degree
• Minimum of 5 years of regulatory affairs experience in biotech or pharmaceutical drug development, with a strong focus on EU and ex‑U.S. clinical trial submissions
• Demonstrated hands-on experience with EU CTA submissions in CTIS, CTA preparation and coordination, health authority interactions and response management
• Strong knowledge of EU regulatory frameworks including EU CTR 536/2014, EMA guidance and CTA requirements, and applicable ICH guidelines
• Experience managing CTA lifecycle activities (amendments, updates, and maintenance)
• Strong project management and organizational skills, with ability to work independently, manage multiple priorities, and meet deadlines in a lean, fast-paced environment
• Demonstrated ability to write clear, accurate regulatory documents
• Detail-oriented with a commitment to quality and compliance
• Strong written and verbal communication skills with a collaborative, team-oriented approach
• Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
• Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude.

Benefits

• This role is also eligible for a competitive total rewards package, which may include an annual bonus, equity, and a comprehensive benefits offering.