Director, Regulatory Affairs
A leading American biopharmaceutical company in the Greater Boston area is seeking a Director, Regulatory Affairs to join its growing team. The company specializes in cellular therapies and biologic products, with a strong focus on regenerative medicine across multiple therapeutic areas. The company operates from a newly built facility and is preparing to launch several new projects in mid-next year. The team is expanding to support both domestic operations and future global initiatives, so this is a great opportunity to join a mission-driven company at a pivotal moment in its development.
This role works closely with the Executive Director of Regulatory Affairs, offering a great opportunity to step into a key leadership position. If you're excited about helping a growing biotech company expand into global markets, and you meet the qualifications below, we'd love to hear from you!
Key Responsibilities:
- Manage, evaluate, and complete regulatory projects consistent with the company goals
- Prepare and manage INDs, BLAs, and other regulatory submissions
- Ensure regulatory documentation is accurate, timely, and aligned with evolving global standards
- Provide guidance to cross-functional teams on regulatory strategy and tactics
- Oversee and mentor a team of four regulatory professionals
Qualifications:
- Bachelor's degree in a scientific discipline (Master's preferred)
- 10+ years of Regulatory Affairs experience
- Proven leadership experience managing regulatory teams and projects
- Experience with drugs, biologics, and/or combination devices
- Strong knowledge of FDA regulations, eCTD structure, and combination product pathways
- Excellent communication, writing, and cross-functional collaboration skills
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