---
title: 'Vice President, CMC Regulatory Affairs at Kailera Therapeutics, Inc.'
canonical: 'https://feeny.ai/job/vice-president-cmc-regulatory-affairs-kailera-therapeutics-inc-united-states-t441rhykr9wc'
type: 'job'
last_seen: '2026-11-07'
---

# Vice President, CMC Regulatory Affairs at Kailera Therapeutics, Inc.

- **Company:** Kailera Therapeutics, Inc.
- **Location:** United States
- **Compensation:** $272k–$340k
- **Work type:** remote
- **Posted:** 2026-10-19
- **Last confirmed live:** 2026-11-07
- **Apply:** https://job-boards.greenhouse.io/kailera/jobs/5454323008

## Job description

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:

Vice President of CMC Regulatory will lead all aspects of CMC Regulatory. Reporting into the Senior Vice President of Regulatory, you will provide strategic and operational leadership to ensure the effectiveness of the CMC Regulatory team and the integrated CMC team. With their lead candidate planning to initiate Phase 3, the candidate must plan for and have extensive drug development expertise. The company offers innovative science, competitive compensation, and a patient-focused company culture.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month).

Responsibilities:

- Develop and own the global CMC regulatory strategy for the portfolio, and provide input to corporate and program strategy, including Phase 3 readiness, marketing application planning, and launch
- Serve as the company's lead CMC voice with FDA, EMA, and other global health authorities, including leading CMC-focused meetings (e.g., End-of-Phase 2, pre-submission, Scientific Advice) and responses to information requests
- Responsible for ensuring the appropriate execution of CMC regulatory strategy
- Set standards and expectations for submission quality and cross-functional delivery and hold the team accountable for results
- Build, lead, and develop a high-performing CMC Regulatory team as the company scales toward registration. This includes organizational design, hiring, succession planning, and coaching managers to grow as leaders
- Oversee all CMC-related submission planning and execution, ensuring that high quality and accurate submission documents are completed within target timelines
- Accurately interpret and discuss data within cross-functional teams and with health authorities
- Anticipate evolving global regulatory expectations and industry trends, advise executive leadership on their impact, and adjust CMC regulatory strategy accordingly
- Lead the preparation of risk assessments on CMC regulatory topics. Predict potential regulatory questions and develop robust contingency and mitigation plans with the integrated CMC team
- Establish and lead strategic relationships with CDMO partners, health authorities, and internal executives, and break down silos to enable integrated CMC execution
- Ensure CMC dossiers meet ICH format and content requirements, as well as specific local requirements of individual countries
- Determine resourcing, budget, and use of external consultants and vendors for CMC Regulatory, and influence resource allocation across the integrated CMC organization (Process Development, Manufacturing, Analytical, Quality)
- Partner with Quality and Technical Operations on commercial manufacturing readiness, process validation, comparability, and pre-approval inspection strategy. Define the post-approval change and lifecycle management strategy

Required Qualifications:

- 15+ years of biopharmaceutical industry experience; with 10+ years of relevant Regulatory CMC
- Demonstrated track record of successful submissions to FDA and/or other health authorities, including EMA
- Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions
- Ability to motivate and lead others, both with direct line and within integrated team
- Excellent interpersonal, verbal and written communication skills as well as the ability to effectively lead and influence others
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

Education:

- BS degree in Biochemistry, Biology, Chemistry, Engineering or related field required; advanced degree preferred

Salary Range $272,000—$340,000 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.

#LI-Hybrid

## About Kailera Therapeutics, Inc.

## Company Overview
- **One-liner**: Kailera Therapeutics is an advanced clinical-stage biotechnology company developing a diversified pipeline of GLP-1‑based therapies for obesity and overweight.
- **Entity Type**: Private (clinical stage; in‑licensed through a strategic collaboration with Jiangsu Hengrui Pharmaceuticals)
- **Headquarters**: Waltham, Massachusetts, United States
- **Founded**: Not publicly available
- **Founders**: Not publicly available

## Core Business
- **Primary industries**: Biotechnology / Obesity therapeutics
- **Target customers**: B2B (pharma partnerships) and ultimately patients and healthcare providers managing obesity and overweight
- **Mission**: To give people the power to restore their health and transform their lives by delivering category‑leading obesity management medications. [kailera.com/about-us](https://www.kailera.com/about-us/)

## Products & Services
Kailera’s pipeline is designed to address diverse unmet needs in obesity care, building on clinical data from Hengrui’s trials in China. All candidates are in‑licensed from Hengrui with exclusive rights outside China, Hong Kong, Macau and Taiwan.

- **Ribupatide (KAI‑9531)** – Once‑weekly injectable GLP‑1/GIP receptor dual agonist peptide; currently in a global Phase 3 program.
- **Ribupatide oral tablet** – Once‑daily oral formulation of the dual agonist.
- **KAI‑7535** – Oral small‑molecule GLP‑1 receptor agonist (clinical stage).
- **KAI‑4729** – Once‑weekly injectable GLP‑1/GIP/glucagon receptor tri‑agonist (clinical stage).

## Market Standing
- **Valuation / Market Cap**: Not disclosed (private company)
- **Key Metric**: Total funding – not publicly available; revenue – none (pre‑commercial). Pipeline lead in Phase 3.
- **Notable Investors / Partners**: Jiangsu Hengrui Pharmaceuticals Co., Ltd. (strategic collaboration and in‑licensing partner). Leadership team includes veterans from Cerevel Therapeutics, Translate Bio, Bain Capital Life Sciences, Amgen, Frazier Life Sciences, and AbbVie. [kailera.com/leadership](https://www.kailera.com/leadership/)
- **Growth Signals**:
  - Ribupatide clinical data presented at the American Diabetes Association (ADA) 2026.
  - Global Phase 3 program underway for ribupatide.
  - Multiple clinical‑stage candidates (oral, small molecule, tri‑agonist) targeting different patient needs.
  - Active hiring with 29 open positions (as of mid‑2026) across R&D, clinical, supply chain, regulatory, and corporate functions. [job-boards.greenhouse.io/kailera](http://job-boards.greenhouse.io/kailera)

## Competitive Advantages
- **Diversified modality pipeline**: Injectable dual agonist, oral formulation, oral small molecule, and tri‑agonist – covering a broad range of patient preferences and treatment stages.
- **Cross‑border development acceleration**: Access to Hengrui’s clinical data from China informs and de‑risks global trials.
- **World‑class leadership**: CEO Ron Renaud (former CEO of Cerevel and Translate Bio, both acquired by AbbVie and Sanofi respectively). CMO Scott Wasserman, M.D. (former CEO of Latigo Biotherapeutics, former Amgen VP leading metabolic and cardiovascular portfolios). Commercial and operational executives from top pharma. [kailera.com/leadership](https://www.kailera.com/leadership/)
- **Obesity‑first focus**: Pipeline deliberately built for the chronic, progressive nature of obesity, aiming to address the gap for greater weight loss and higher‑BMI patients.

## Strategic Focus
Kailera’s immediate priority is advancing ribupatide through Phase 3 to regulatory submission while progressing the earlier‑stage oral and tri‑agonist programs. The company aims to “elevate the next era of obesity care” by delivering multiple options for patients no matter where they are in their treatment journey. [kailera.com/](https://www.kailera.com/)

## Why Work Here
- **Culture (“Kai Values”)**: Emphasizes courage, collaboration, compassion, and commitment. The team operates with entrepreneurial spirit, transparency, and a patient‑centered mission. [kailera.com/join-our-team](https://www.kailera.com/join-our-team/)
- **Work Model**: Hybrid and remote options available – many roles are based in Waltham, MA, but some (e.g., Statistical Programming, Clinical Quality Assurance) are listed as US‑Remote.
- **Notable Perks**: Purpose‑driven work in a fast‑growing therapeutic area; opportunity to work with top industry veterans; exposure to a pipeline that spans multiple cutting‑edge modalities (injectable, oral, small molecule).
- **Growth Opportunity**: With 29 open positions across all levels (Associate Director to Senior Director), the company is scaling rapidly, offering significant career advancement in a high‑impact field.

## Sources
1. [kailera.com](https://www.kailera.com/)
2. [kailera.com/about-us](https://www.kailera.com/about-us/)
3. [kailera.com/leadership](https://www.kailera.com/leadership/)
4. [kailera.com/join-our-team](https://www.kailera.com/join-our-team/)
5. [job-boards.greenhouse.io/kailera](http://job-boards.greenhouse.io/kailera)

## Other roles at Kailera Therapeutics, Inc.

- [Associate Director, Clinical Scientist](https://feeny.ai/job/associate-director-clinical-scientist-kailera-therapeutics-inc-waltham-sgrctnmfaxpv) — Waltham, MA
- [Associate Director, Program Management (Early Pipeline)](https://feeny.ai/job/associate-director-program-management-early-pipeline-kailera-therapeutics-inc-d3xve0y35etn) — Waltham, MA
- [Senior Director, Drug Substance Commercial Manufacturing](https://feeny.ai/job/senior-director-drug-substance-commercial-manufacturing-kailera-therapeutics-wxj0jjh230fc) — United States
- [Director, Drug Substance Commercial Manufacturing](https://feeny.ai/job/director-drug-substance-commercial-manufacturing-kailera-therapeutics-inc-dmr3vs8w638q) — United States
- [Senior Director, Alliance Management](https://feeny.ai/job/senior-director-alliance-management-kailera-therapeutics-inc-united-states-68myhez9bm6n) — United States
- [Manager, Patient Retention](https://feeny.ai/job/manager-patient-retention-kailera-therapeutics-inc-waltham-tewqr6aad1a2) — Waltham, MA
- [Director, Analytical Development and Quality Control](https://feeny.ai/job/director-analytical-development-and-quality-control-kailera-therapeutics-inc-dcvdqtvsxt3e) — United States
- [Associate Director, CMC Operations](https://feeny.ai/job/associate-director-cmc-operations-kailera-therapeutics-inc-united-states-39cdrzcbwtbm) — United States
- [Vice President, Global Supply Chain](https://feeny.ai/job/vice-president-global-supply-chain-kailera-therapeutics-inc-united-states-1z9qjwy9fyqy) — United States
- [Vice President, CMC Development and Drug Delivery Innovation](https://feeny.ai/job/vice-president-cmc-development-and-drug-delivery-innovation-kailera-egdk13skt2za) — United States