New · posted Oct 20
Kailera · Biotechnology
Vice President, CMC Regulatory Affairs
- Remote, US) or Waltham, MA
- Remote
- Full-time
- VP & Executive
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
- 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
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).
- 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
Pay and benefits
$272,000 – $340,000 a year
Employer provided$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.
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 20, 2026
Salary intelligence
How the pay compares
This roleEmployer provided
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $272,000 | — | $340,000 |
This role: Kailera's own published range.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 86 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not Kailera's own promotion track.
Career resources on Regulatory CMC
Skills DNA
What this role leans on
How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership11
- Regulatory submissions10
- Documentation and SOPs2
- GMP and compliance1
- Lab testing and methods1
- Validation and qualification1
- Quality systems and risk1
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.
Company hiring pulse
Kailera on Regulatory Jobs
- 7
- Open roles
- 7
- Distinct roles
- 3
- Locations
By discipline
- Regulatory6 86%
- Quality1 14%
By level
- Director5 71%
- VP & Executive1 14%
- Senior & Principal1 14%
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Vice President, CMC Regulatory Affairs at Kailera
Open until filled. $272K–$340K a year, employer provided.