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 $192,000—$235,000 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.
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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 $192,000—$235,000 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.
#J-18808-Ljbffr