Director, CMC Regulatory Affairs

What You’ll Do

Reporting to the Vice President, CMC Regulatory, the Director of Regulatory Affairs, CMC will support the development and execution of global regulatory CMC strategies. This individual will ensure that regulatory strategies are effectively implemented and maintained in line with changing regulatory and business needs. They will support the day‑to‑day regulatory activities of assigned products, identify and gather data needed to support filings, respond to inquiries, and maintain registrations to enable commercialization of products that meet relevant global regulatory requirements.

Additionally, they will manage regulatory submission processes and timelines, regulatory tracking tools, archives, and infrastructure, as assigned.

Location
:
Waltham, MA (hub‑based, onsite 3‑4 days per week)

• Responsible for one or more product(s) and support the regulatory CMC team in the development and 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.
• Lead CMC preparation activities for meetings with Health Authorities on CMC‑related matters.
• Ensure timely preparation of CMC documents and be 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 risks promptly to the regulatory CMC team.
• Oversee the copyediting, finalization, approval, and hand‑off of documents for publishing.

• 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 with outstanding work ethic; able to perform in a fast‑paced environment.
• Demonstrates leadership, problem‑solving ability, attention to detail, flexibility, and values teamwork.
• Exercises good judgment 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 (e.g., to attend health authority meetings).

• Experience with peptides is preferred.

• BS/BA Degree in a scientific discipline.
• Advanced degree in a scientific discipline (preferred).

Salary Range
: $175,000—$230,000 USD

Benefits
:
Comprehensive health coverage, flexible time off, paid holidays, and a year‑end shutdown. Monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, annual bonus opportunities, and equity grants.

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender, gender identity or expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, or political affiliation.

Kailera Therapeutics, Inc. uses E‑Verify to confirm the identity and employment eligibility of all new hires.

Seniority level
:
Director

Employment type
:
Full‑time

Job function
:
Legal