The Director, CMC Regulatory Affairs at Kailera Therapeutics will support the development and execution of global regulatory CMC strategies, ensuring compliance with changing regulatory and business needs. This role involves managing day-to-day regulatory activities for assigned products, identifying data for filings, and overseeing submission processes. The director will also lead CMC preparation for Health Authority meetings and contribute to evaluating change proposals for global regulatory impact.

Must Have

• Support the development and execution of global regulatory CMC strategies
• Plan and execute regulatory submissions for assigned compounds in clinical development, global marketing applications, and post-approval life cycle activities
• Define CMC content requirements for regulatory submissions and conformance
• Lead CMC preparation activities for meetings with Health Authorities
• Ensure timely preparation of CMC documents and hand-off submission-ready documents
• Contribute to the evaluation of change proposals for global regulatory impact
• Identify and communicate critical topics and risks promptly
• Oversee copyediting, finalization, approval, and hand-off of documents for publishing
• 10+ years regulatory CMC experience, including as a regulatory CMC product lead
• 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
• Self-starter and results-oriented individual with outstanding work ethic
• 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
• BS/BA Degree in a scientific discipline

Good to Have

• Experience with peptides
• Advanced degree in a scientific discipline

Perks & Benefits

• Comprehensive health coverage
• Flexible time off
• Paid holidays
• Year-end shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Tuition reimbursement
• Commuter benefits
• Disability insurance
• Life insurance
• Annual bonus opportunities
• Equity grants

Director, CMC Regulatory Affairs

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.

We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

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, responses to inquiries, and registration maintenance to enable commercialization of products that are developed to meet relevant global regulatory requirements. Additionally, they will manage regulatory submission processes and timelines, regulatory tracking tools, archives, and infrastructure, as assigned.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

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

Required Qualifications:

• 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)

Preferred Qualifications:

• Experience with peptides is preferred

Education:

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

Salary Range

$175,000 - $230,000 USD

For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify:

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

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