---
title: 'Associate Director, Global Regulatory Affairs at Kailera Therapeutics, Inc.'
canonical: 'https://feeny.ai/job/associate-director-global-regulatory-affairs-kailera-therapeutics-inc-waltham-zfq2ybe43kx0'
type: 'job'
last_seen: '2026-09-05'
---

# Associate Director, Global Regulatory Affairs at Kailera Therapeutics, Inc.

- **Company:** Kailera Therapeutics, Inc.
- **Location:** Waltham, MA
- **Compensation:** $155k–$190k
- **Posted:** 2026-07-30
- **Last confirmed live:** 2026-09-05
- **Apply:** https://job-boards.greenhouse.io/kailera/jobs/5019378008

## 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:

The Associate Director, Global Regulatory Affairs will be responsible for day-to-day regulatory activities of early/late phase investigational products, leading the writing and submission of IND/CTA/amendments and future marketing application submissions, providing guidance to the team on regulatory filings and responses, and providing critical regulatory intelligence and guidance back to the team. The Associate Director will work on cross-functional teams, partnering with key internal/external team members including Regulatory CMC and Regulatory Operations to ensure the scientific data and submissions fulfills agency expectations in a compliant manner.

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

Responsibilities:

- Serve as the regulatory representative on core teams, developing and planning regulatory submission strategies, coordinating the preparation of submissions to regulatory agencies, and conducting regulatory intelligence activities
- Oversee the compilation, review, and submission of regulatory applications and submissions to agencies, ensuring accuracy, completeness, and timeliness
- Monitor the regulatory environment and communicate developments to various stakeholders within the company (clinical, regulatory, senior leadership, etc)
- Stay updated on global regulatory guidance and regulations, communicating key updates to senior leadership and project team management to ensure compliance with all reporting requirements, including annual and periodic reports
- Respond to regulatory questions from various regulatory authorities, working in collaboration with subject matter experts in clinical development, safety, and other business partners
- Provide strategic regulatory guidance for global development and registration programs (e.g., INDs, CTAs, NDAs, and MAAs)
- Assess and communicate regulatory requirements to ensure all development activities follow applicable regulations and guidelines
- Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs

Required Qualifications:

- Demonstrated knowledge of regulatory requirements in the design and conduct of clinical trials, including preparation of regulatory submissions
- Established working knowledge of regulatory guidelines and regulations (US and international)
- Demonstrated deep knowledge of the integrated drug development process
- Demonstrated ability to find solutions and alternatives through teamwork resulting in positive business outcomes
- Demonstrated ability to assess and manage risk in a highly regulated environment
- Strong written, spoken, and presentation communication
- Strong desire to grow career in the pharmaceutical industry, willingness to learn, and enthusiastically embrace new opportunities
- Travel expected (10-15%)

Preferred Qualifications:

- Advanced degree preferred

Education:

- Bachelors degree with 10+ years of relevant drug development experience
- Advanced degree (such as PhD, PharmD, MS, MBA) with at least 5 years of relevant drug development experience

Salary Range $155,000—$190,000 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.

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