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Kailera Therapeutics Logo Kailera Therapeutics · IT - Administration

Director, Global Regulatory Affairs (Submission Project Management)

United States, Waltham 175000.00 - 230000.00 USD / Year · Job Posted January 03, 2026
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Job Description

The Director of Global Regulatory Affairs (Submission Project Management) is responsible for leading regional and global cross-functional teams in the planning, preparation, and delivery of compliant marketing authorization filings. This role combines strategic leadership with hands-on project management to ensure timely and high-quality submissions that support product approvals, lifecycle management, and organizational growth.

Job Responsibility

  • Contribute to and lead the execution of submission strategies in alignment with corporate objectives and regulatory requirements
  • Provide guidance on evolving global regulatory landscapes, including guidelines, regulations, and other factors related to regulatory filings
  • 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
  • Liaising with regulatory operations department to ensure all components are identified on the submission content plans and submissions meet technical, formatting, and compliance standards
  • Develop and manage marketing authorization project timelines and deliverables
  • Identify risks and manage operational risks, implementing mitigation/contingency strategies to ensure submission success
  • Track progress and report status updates to executive leadership
  • Establish best practices and SOPs as needed for marketing application related submission processes
  • Ensure adherence to ICH, FDA, EMA, and other global regulatory regulations/guidelines
  • Build strong collaborative relationships across departments

Requirements

  • 10+ years (8+ with advanced degree) of regulatory affairs and/or project management experience
  • Proven track record managing global submissions (NDA, BLA, MAA)
  • Deep expertise in the integrated drug development process, ensuring seamless progression from discovery through commercialization
  • Collaborated effectively across multidisciplinary teams to identify innovative solutions and alternatives, driving positive business outcomes
  • Expertly assessed and mitigated risk within a highly regulated environment, maintaining compliance while advancing critical projects
  • Strong project management skills (PMP certification a plus), with proficiency in Microsoft Project, SmartSheet, or Planisware
  • Excellent communication, organizational, and leadership abilities
  • Ability to thrive in a fast-paced, deadline-driven environment
  • Demonstrated negotiation and influence skills
  • Bachelor’s degree with regulatory and/or project management experience in the pharmaceutical industry

Nice to have

  • Experience in international regulatory submissions and regulatory interactions
  • Previous regulatory or leadership assignments across multiple countries
  • Advanced degree in Life Sciences, Regulatory Affairs, or related field (PhD, PharmD, MS preferred)

What we offer

  • 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
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