Kailera Therapeutics

Clinical-stage obesity and metabolic drugs developer

Associate Director - Global Regulatory Affairs

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-time

About the Job

Requirements

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 in the United States and internationally.
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 skills.
A bachelor's degree and 10+ years of relevant drug development experience, or an advanced degree such as a PhD, PharmD, MS, or MBA and at least 5 years of relevant drug development experience.
Travel expected at 10–15%.

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 stakeholders across clinical, regulatory, and senior leadership teams.
Stay updated on global regulatory guidance and regulations, communicate key updates to senior leadership and project team management, and ensure compliance with reporting requirements, including annual and periodic reports.
Respond to questions from regulatory authorities in collaboration with subject matter experts in clinical development, safety, and other business partners.
Provide strategic regulatory guidance for global development and registration programs, including INDs, CTAs, NDAs, and MAAs.
Assess and communicate regulatory requirements to ensure development activities follow applicable regulations and guidelines.
Contribute to implementing processes and procedures, including developing and authoring internal work instructions and company standard operating procedures.
Conduct day-to-day regulatory activities for early- and late-phase investigational products, lead the writing and submission of INDs, CTAs, and amendments, and support future marketing application submissions.
Provide guidance to the team on regulatory filings and responses and provide regulatory intelligence and guidance to the team.
Partner with internal and external team members, including Regulatory CMC and Regulatory Operations, to ensure scientific data and submissions meet agency expectations in a compliant manner.

Desired Qualifications

An advanced degree is preferred.

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) OR Remote (home-based, onsite at a hub 1 week every other month).

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.

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Salary Range 155000 - 190000 USD

About the Company

Kailera Therapeutics

Clinical-stage obesity and metabolic drugs developer

Kailera Therapeutics focuses on obesity and related metabolic conditions by acquiring and developing clinical-stage drug candidates and moving them toward commercialization. Its lead asset, KAI-9531, is an injectable dual agonist of GLP-1 and GIP receptors for obesity and type 2 diabetes, and the pipeline includes an oral GLP-1 agonist (KAI-7535), an oral tablet form of KAI-9531, and an injectable tri-agonist targeting GLP-1, GIP, and glucagon receptors (KAI-4729). The company differentiates itself by sourcing assets outside of early research, pursuing a mix of injectable and oral therapies, and leveraging a high-profile leadership team and substantial funding to progress a broad portfolio under external licenses. Kailera’s goal is to advance multiple metabolic disease therapies from clinical development toward commercialization to improve outcomes for patients with obesity and related conditions.

Company size: 51-200
Company stage: IPO
Headquarters: Waltham, MA
Founded: 2024

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