New · posted Oct 15
Kailera · Biotechnology
Associate Director, Global Regulatory Affairs
- Remote, US
- Remote
- Full-time
- Director
Open until filled
The role
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 need
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%)
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
Preferred Qualificationsnice to have
- Advanced degree preferred
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.
- 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
Pay and benefits
$155,000 – $190,000 a year
Employer provided$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.
Comprehensive health coverage
Flexible time off
401(k) match
Monthly wellness stipend
Tuition reimbursement
Annual bonus and equity grants
Equal opportunity, accessibility and legal noticesKailera's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 27% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Director roles in the US101 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $155,000 | — | $190,000 |
| All US (middle half) | $209,500 | $235,000 | $264,000 |
This role: Kailera's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Kailera's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- Regulatory submissions4
- GMP and compliance3
- Documentation and SOPs3
- Investigations and CAPA1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Kailera on Regulatory Jobs
- 5
- Open roles
- 5
- Distinct roles
- 2
- Locations
By discipline
- Regulatory4 80%
- Quality1 20%
By level
- Director4 80%
- Senior & Principal1 20%
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Associate Director, Global Regulatory Affairs at Kailera
Open until filled. $155K–$190K a year, employer provided.