Director, Regulatory Submissions & MA Strategy (Remote)

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

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