Director, Program Management (Regulatory Submissions)

Regulatory Jobs; United States; Hybrid; USD 155,000 - 235,000; Full time

Benefits offered by this job

Health coverage

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 an Associate Director/Director, Program Management to lead regional and global teams in planning, preparation, and delivery of compliant marketing authorization filings.

You will oversee project plans from initiation to completion, ensuring on-time delivery within scope and budget, while proactively addressing risks with cross-functional partners. A successful candidate will have extensive drug development experience, strong collaboration skills, and a track

Qualifications

• 10+ years of project management experience in biotech/pharma/life sciences
• Strong understanding of drug development and biotech functions
• Experience in managing cross-functional teams and complex projects with global MA submissions (NDA, BLA, MAA) preferred
• Demonstrated PM and interpersonal skills
• Excellent problem-solving and organizational skills, attention to detail and analytical skills
• Ability to manage multiple priorities in a fast-paced environment
• Comfortable navigating ambiguity and driving clarity
• Proven collaboration and communication skills

Responsibilities

• Contribute to and lead the execution of submission strategies aligned with regulatory requirements
• Lead cross-functional submission team meetings and workstreams (Regulatory, Clinical, Quality, CMC, Medical Writing)
• Oversee project team delivery of marketing authorization applications
• Develop and own detailed integrated MA plans with goals, deliverables, timelines, and resource needs
• Monitor progress and provide updates to Program Leader and stakeholders
• Own program reports/dashboards to governance teams
• Establish SOPs for submission processes

Skills

Cross-functional collaboration

Project management

Biotech knowledge

Regulatory submissions

Communication

Leadership

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 an Associate Director/Director, Program Management to lead regional and global teams in planning, preparation, and delivery of compliant marketing authorization filings.

You will oversee project plans from initiation to completion, ensuring on-time delivery within scope and budget, while proactively addressing risks with cross-functional partners. A successful candidate will have extensive drug development experience, strong collaboration skills, and a track