Support the development and execution of regulatory strategies for assigned programs.
Serve as a key regulatory contributor on cross-functional project teams.
Support interactions with U.S. and global health authorities.
Emphasize hands-on regulatory execution, document preparation, and cross-functional coordination.
Identify and communicate regulatory considerations, risks, and mitigation strategies.
Draft, review, and coordinate regulatory documents for submissions.
Provide regulatory input to CMC teams related to manufacturing changes, comparability, specifications, and lifecycle management.
Act as a regulatory representative on project teams, working closely with Clinical Development and other departments.

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.

Manager, Regulatory Affairs – CMC, Clinical

Key skills