Director, Global Program Management – Regulatory Submissions

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

Benefits offered by this job

Comprehensive health coverage

Flexible time off

Paid holidays

Year-end shutdown

Monthly wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability and life insurance

Annual bonus opportunities

Equity grants

Job summary

Kailera Therapeutics, Inc. seeks an Associate Director/Director, Program Management to lead cross-functional teams in planning and delivering compliant marketing authorization filings.

You will manage timelines, budgets, and risk while partnering with regulatory, clinical, quality, and CMC groups to drive successful submissions. Ideal candidates have 10+ years in biotech/pharma project management, strong regulatory submission experience, and excellent communication skills to coordinate global

Qualifications

• 10+ years of project management experience in biotech/pharma or life sciences.
• Strong understanding of drug development and cross-functional integration.
• Experience managing global marketing authorization submissions (NDA, BLA, MAA) preferred.

Responsibilities

• Lead regional and global cross-functional teams for compliant marketing authorization filings.
• Develop and own detailed integrated marketing authorization plans with timelines and resources.
• Monitor progress, provide updates to governance teams, and manage program reports/dashboards.
• Establish SOPs and best practices for submission processes.

Skills

Project management

Cross-functional leadership

Biotech/pharma industry experience

Regulatory submissions

Communication

Risk management

Problem solving

Education

Bachelor's degree in science/engineering

Advanced degree preferred

Tools

Smartsheet

MS Project

Excel

think-cell

OnePager

Job description

Kailera Therapeutics, Inc. seeks an Associate Director/Director, Program Management to lead cross-functional teams in planning and delivering compliant marketing authorization filings.

You will manage timelines, budgets, and risk while partnering with regulatory, clinical, quality, and CMC groups to drive successful submissions. Ideal candidates have 10+ years in biotech/pharma project management, strong regulatory submission experience, and excellent communication skills to coordinate global