Director, Program Management Regulatory Submissions

Kailera Therapeutics, Inc.; Waltham (MA); Hybrid; USD 192,000 - 235,000; Full time

Benefits offered by this job

Health coverage

Flexible time off

Paid holidays

Year-end shutdown

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability insurance

Life insurance

Annual bonus

Equity grants

Job summary

Kailera Therapeutics, Inc. in Waltham, MA is seeking a Director, Program Management Regulatory Submissions to lead regional and global teams in planning, prep, and delivery of compliant marketing authorization filings.

You will oversee project plans from initiation to completion, ensuring on-time, within-scope, and within-budget execution. You will collaborate with regulatory, clinical, quality, and CMC groups, build relationships across functions, and drive risk identification and mitigation in

Qualifications

• 10+ years of project management experience in biotech, pharmaceutical, or life sciences.
• Strong understanding of drug development and cross-functional integration.
• Experience leading global regulatory submissions (NDA/BLA/MAA) preferred.
• Proven leadership, communication, and problem-solving skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Bachelor’s degree in science, engineering, or related field; advanced degree preferred.

Responsibilities

• Lead regional and global cross-functional teams to plan, prepare, and deliver regulatory submissions.
• Develop and own detailed integrated marketing authorization plans with timelines and resources.
• Oversee project delivery and ensure on-time, in-scope, and on-budget execution.
• Proactively identify risks and implement effective mitigation strategies.
• Maintain program reports and dashboards for executives and governance.

Skills

Project management

Cross-functional collaboration

Regulatory submissions

Problem-solving

Communication

Attention to detail

Education

Bachelor's degree in science/engineering

Advanced degree preferred

Tools

Smartsheet

MS Project

Excel

think-cell

OnePager

Job description

Director, Program Management Regulatory Submissions

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 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.

Location: Waltham, MA(hub-based, onsite 3-4 days per week) preferred, open to Remote

Responsibilities:

• 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

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

Salary Range

$192,000 - $235,000 USD

Salary Range (Associate Director)

$155,000 - $190,000 USD

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.

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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