New · posted Oct 15
Kailera · Biotechnology
Associate Director/Director, Program Management (Regulatory Submissions)
- 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
- 10+ years of relevant experience of project management experience in the biotech, pharmaceutical, or life sciences industry
- Strong understanding of drug development and how biotech functions integrate
- Experience in managing cross-functional teams and complex projects inate-stage drug development, with experience managing global marketing authorization submissions (NDA, BLA, MAA) preferred
- Demonstrated project management and interpersonal skills
- Excellent problem-solving and organizational skills, attention to detail, and analytical skills
- Ability to manage multiple priorities in a fast-paced, dynamic environment
- Comfortable navigating ambiguity and driving clarity
- Responds to changing priorities and uncertainty by maintaining composure, resilience, and an open mind while embracing change in an evolving environment
- Proven record of collaboration and excellent communication
- Proficient in project management tools (e.g., Smartsheet, MS Project, Excel, think-cell, OnePager)
Education
- Bachelor’s degree in science, engineering, or a related field; advanced degree preferred
- Associate Director: advanced degree 5+ years of experience
- Director: advanced degree 8+ years of experience
This role may be hired at the Associate Director or Director level depending on candidate experience or business need.
What you'll do
The Associate Director/Director, Program Management will collaborate with cross-functional teams, including clinical, regulatory, non-clinical, and technical operations, to lead regional and global cross-functional teams in the planning, preparation, and delivery of compliant marketing authorization filings. This individual will oversee the development and execution of project plans from initiation to completion, ensuring the plan is completed on time, in scope, and within budget. Additionally, they will work closely with teams to proactively identify potential risks and implement effective solutions. A successful candidate must have experience managing drug development projects, particularly initial marketing authorization applications, in a fast-paced environment, with a strong willingness to build relationships with cross-functional teams, dive into details, and address gaps as needed to ensure program success.
- Contribute to and lead the execution of submission strategies in alignment with corporate objectives and regulatory requirements
- Lead and manage cross-functional submission team meetings and workstreams (Regulatory, Clinical, Quality, CMC, Medical Writing)
- Oversee project team delivery of the marketing authorization applications
- Develop and own detailed integrated marketing authorization plans, including goals, deliverables, timelines, and resource requirements
- Monitor project progress and provide regular updates to Program Leader and other stakeholders, ensuring clear communication and transparency
- Own program reports / dashboards to executive and other governance teams
- Establish best practices and SOPs as needed for marketing application related submission processes
Pay and benefits
$155,000 – $235,000 a year
Employer provided$155,000—$190,000 USD
Salary Range (Associate Director)
Salary Range (Director)
$192,000—$235,000 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 17% 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 | — | $235,000 |
| 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
- Documentation and SOPs4
- Regulatory submissions4
- Lab testing and methods1
- Data and digital systems1
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.
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
- FDAFDA BLA(official source, opens in a new tab)Biologics License Applications
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/Director, Program Management (Regulatory Submissions) at Kailera
Open until filled. $155K–$235K a year, employer provided.