Director, Global Regulatory Affairs (Submission Project Management)
Kailera Therapeutics, Inc.Waltham, Massachusetts, United States
Posted February 20, 2026
192000 - 235000 USD
Full Time
About the Company
Kailera is a biopharmaceutical company dedicated to developing therapies for obesity and related conditions.
Job Description
We are seeking a Director, Global Regulatory Affairs (Submission Project Management) to lead regional and global cross-functional teams in the planning, preparation, and delivery of compliant marketing authorization filings. The role combines strategic leadership with hands-on project management to ensure timely and high-quality submissions that support product approvals, lifecycle management, and organizational growth.
Requirements
- 10+ years of regulatory affairs and/or project management experience
- Proven track record managing global submissions (NDA, BLA, MAA)
- Deep expertise in the integrated drug development process
- Strong project management skills (PMP certification a plus)
- Excellent communication, organizational, and leadership abilities
Benefits
- Comprehensive health coverage
- Flexible time off
- Paid holidays
- Year-end shutdown
- Monthly wellness stipend
- Generous 401(k) match
- Tuition reimbursement
- Commuter benefits
- Disability and life insurance
- Annual bonus opportunities and equity grants
