Director, Program Management Regulatory Submissions

The role

The Director, Program Management Regulatory Submissions will lead regional and global cross-functional teams in the planning, preparation, and delivery of compliant marketing authorization filings. This role involves overseeing project plans from initiation to completion to ensure they are on time, in scope, and within budget.

What you will do

• Lead the execution of submission strategies in alignment with corporate objectives and regulatory requirements
• Lead and manage cross-functional submission team meetings and workstreams
• Oversee project team delivery of the marketing authorization applications
• Develop and own detailed integrated marketing authorization plans
• Monitor project progress and provide regular updates to Program Leader and stakeholders
• Own program reports and dashboards to executive and other governance teams
• Establish best practices and SOPs for marketing application related submission processes

Required qualifications

• 10+ years of relevant project management experience in the biotech, pharmaceutical, or life sciences industry
• Strong understanding of drug development and how biotech functions integrate
• 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
• Proven record of collaboration and excellent communication
• Proficient in project management tools (e.g., Smartsheet, MS Project, Excel, think-cell, OnePager)
• Bachelor’s degree in science, engineering, or a related field

Nice to have

• Experience managing global marketing authorization submissions (NDA, BLA, MAA)
• Advanced degree

Benefits

• Comprehensive health coverage
• Flexible time off
• Paid holidays
• Year-end shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Tuition reimbursement
• Commuter benefits
• Disability and life insurance
• Annual bonus opportunities
• Equity grants

Before you apply

• Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires

About the company

Kailera is working to advance novel therapies for obesity and related conditions. The company is rooted in an entrepreneurial spirit and a team-oriented culture.