New · posted Nov 11
Kailera · Biotechnology
Director, Program Management Regulatory Submissions
- Remote, US
- Remote
- Full-time
- Director
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
What you'll do
The Director, Program Management Regulatory Submissions 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$192,000—$235,000 USD
Salary Range (Associate Director)
$155,000—$190,000 USD
Salary Range (Director)
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
Tuition reimbursement
Monthly wellness stipend
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 · November 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is 2% above the US median for Regulatory Project Management roles at this level.
This roleEmployer provided
Director roles in the US9 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $155,000 | — | $235,000 |
| All US (middle half) | $182,000 | $192,000 | $198,500 |
This role: Kailera's own published range. Comparisons: the base pay employers published on open Regulatory Project Management roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Project Management
The general path across 21 open Regulatory Project Management roles on Regulatory Jobs, with the titles they carry most. Not Kailera's own promotion track.
Career resources on Regulatory Project Management
Skills DNA
What this role leans on
How many of the posting's 20 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- Regulatory submissions5
- Documentation and SOPs4
- Lab testing and methods1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Project Management work in biotechnology, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)Named in the posting
- FDA21 CFR Part 601(official source, opens in a new tab)Licensing of biological products and changes to an approved BLANamed in the posting
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- ICHICH M4 (CTD)(official source, opens in a new tab)The Common Technical Document: how a registration dossier is organized
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- FDAFDA eCTD(official source, opens in a new tab)The electronic Common Technical Document format for drug and biologic submissions
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- FDAFDA expedited programs(official source, opens in a new tab)Fast track, breakthrough therapy, accelerated approval and priority review
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- EURegulation (EC) 1234/2008(official source, opens in a new tab)EU variations to the terms of a marketing authorization
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
- FDA21 CFR Part 1271(official source, opens in a new tab)Human cells, tissues, and cellular and tissue-based products
- FDAFDA Electronic Submissions Gateway(official source, opens in a new tab)The agency-wide gateway for receiving electronic regulatory submissions
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Kailera on Regulatory Jobs
- 14
- Open roles
- 14
- Distinct roles
- 3
- Locations
By discipline
- Regulatory7 50%
- Clinical6 43%
- Quality1 7%
By level
- Director10 71%
- VP & Executive2 14%
- Manager1 7%
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Director, Program Management Regulatory Submissions at Kailera
Open until filled. $155K–$235K a year, employer provided.