Director, Regulatory Submissions & Program Management

Kailera Therapeutics, Inc.; United States; Hybrid; USD 192,000 - 235,000; Full time

Benefits offered by this job

Health coverage

Flexible time off

Paid holidays

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability and life insurance

Annual bonus opportunities

Equity grants

Job summary

Kailera Therapeutics, Inc. is seeking a Director of Program Management Regulatory Submissions to lead global regulatory filings for marketing authorizations. The role collaborates across clinical, regulatory, CMC, and medical writing to ensure timely, compliant submissions and robust program delivery.

Location: Waltham, MA (onsite 3-4 days/week) with remote options; the position emphasizes strategic planning, risk management, and cross-functional leadership in a fast-paced biotech environment.

Qualifications

• 10+ years of project management experience in biotech/pharmaceutical or life sciences.
• Strong understanding of drug development and how biotech functions integrate.
• Experience in managing cross-functional teams and complex projects in late-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
• Proven record of collaboration and excellent communication
• Proficient in project management tools (e.g., Smartsheet, MS Project, Excel, think-cell, OnePager)

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

Skills

Project management

Cross-functional leadership

Drug development knowledge

Interpersonal skills

Problem solving

Organizational skills

Communication

Prioritization

Ambiguity navigation

Collaboration

Education

Bachelor's degree in science/engineering

Advanced degree preferred

Tools

Smartsheet

MS Project

Excel

think-cell

OnePager

Job description

Kailera Therapeutics, Inc. is seeking a Director of Program Management Regulatory Submissions to lead global regulatory filings for marketing authorizations. The role collaborates across clinical, regulatory, CMC, and medical writing to ensure timely, compliant submissions and robust program delivery.

Location: Waltham, MA (onsite 3-4 days/week) with remote options; the position emphasizes strategic planning, risk management, and cross-functional leadership in a fast-paced biotech environment.