Kailera Therapeutics · 1 day ago
Director, CMC Regulatory Affairs
Greater Boston
Full-time
Onsite
Director/Executive
$175K/yr - $230K/yr
10+ years expKailera Therapeutics is committed to developing therapies that transform lives and improve health. The Director of Regulatory Affairs, CMC will support the development and execution of global regulatory strategies, manage regulatory submission processes, and ensure compliance with relevant global regulatory requirements.
BiotechnologyPharmaceuticalTherapeutics
Responsibilities
Responsible for one or more product(s) and supports the regulatory CMC team in the development & execution of global regulatory strategies that expedite development, maximize the probability of success, and mitigate risks
Plan and execute regulatory submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities
Define CMC content (data and documentation) requirements for regulatory submissions and conformance with established requirements
Leads CMC preparation activities for meetings with Health Authorities on CMC related matters
Ensure timely preparation of CMC documents and responsible for handing off submission ready documents for regulatory submissions
Contribute to the evaluation of change proposals for global regulatory impact and support planned global variations and amendments
Identify and communicate critical topics and risk promptly to the regulatory CMC team
Oversee the copyediting, finalization, approval, and hand-off of documents for publishing
Qualification
Required
10+ years regulatory CMC experience, including experience as a regulatory CMC product lead, or equivalent industry experience
Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support
Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams
Able to work independently and complete projects with minimal oversight, escalating issues to regulatory management with discretion
Self-starter and results-oriented individual with outstanding work ethic; must be able to perform in a fast-paced environment
Demonstrates leadership, problem-solving ability, attention to detail, flexibility, and values teamwork
Exercises good judgement in elevating and communicating actual or potential issues to line management
Ability to multi-task and adjust priorities quickly while working under tight deadlines
Experience using electronic document management systems and document review tools
Domestic or international travel may be required (eg, to attend health authority meetings)
BS/BA Degree in a scientific discipline
Preferred
Experience with peptides is preferred
Advance degree in a scientific discipline (preferred)
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
Equity grants
Company
Kailera Therapeutics
Kailera Therapeutics develops next-generation injectable and oral therapies for chronic weight management.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$1BKey Investors
Bain Capital Private Equity
2025-10-14Series B· $600M
2024-10-01Series A· $400M
Leadership Team
Ron Renaud
President & CEO
Doug Bakan
Chief Technology Officer
Recent News
2026-01-05
2025-12-24
2025-12-17
Company data provided by crunchbase