Manager, Regulatory Affairs (CMC & Clinical)

🌍 Remote, USA 🎯 Full-time 🕐 Posted Recently

Job Description

About the position

The Manager, Regulatory Affairs will support the development and execution of regulatory strategies for assigned programs, with a balanced focus on CMC and Clinical Regulatory Affairs. This role will serve as a key regulatory contributor on cross-functional project teams and support interactions with U.S. and global health authorities under the direction of senior regulatory leadership. The position emphasizes hands-on regulatory execution, document preparation, and cross-functional coordination across clinical development and CMC activities from IND through early commercialization.
Location: Remote

Contribute to regulatory strategy development for assigned programs under the guidance of senior regulatory leadership.
Identify and communicate regulatory considerations, risks, and mitigation strategies related to CMC and Clinical activities in a phase-appropriate manner.
Support global regulatory planning across development stages (IND through post-approval).
Draft, review, and coordinate regulatory documents for submissions including INDs, IND amendments, annual reports, briefing documents, IBs, and responses to health authority requests.
Support the preparation of clinical and CMC sections of regulatory submissions ensuring accuracy, clarity, and compliance with applicable regulations (FDA, EMA, ICH).
Ensure regulatory documents meet quality, formatting, and submission readiness standards.
Provide regulatory input to CMC teams related to manufacturing changes, comparability, specifications, and lifecycle management.
Review clinical documents including protocols, ICFs, CSRs, DSURs, and study plans to ensure regulatory compliance.
Support alignment between clinical development plans and CMC readiness.
Act as a regulatory representative on project teams, working closely with Clinical Development, CMC, Quality, Nonclinical, and Regulatory Operations.
Coordinate regulatory activities and timelines to support development milestones.
Prepare internal regulatory updates and contribute to team presentations as needed
Support preparation for health authority meetings, including briefing packages and Q&A documents.
Participate in agency communications as appropriate, under the direction of senior regulatory leadership.
Ensure compliance and regulatory obligations are handled in accordance with SOPs and applicable regulations.
Maintain up-to-date knowledge of regulatory guidelines and industry trends relevant to CMC and clinical development.

Bachelor’s degree in a scientific or related discipline.
Five (5) years of regulatory affairs experience in pharmaceutical or biotechnology development.
Demonstrated experience supporting IND-stage and/or clinical development programs.
Experience drafting regulatory documents and supporting regulatory submissions
Working knowledge of CMC and clinical regulatory requirements.
Familiarity with eCTD structure and regulatory documentation standards