Director, Global Regulatory Affairs (Submission Project Management)

Kailera Therapeutics is seeking a Director, Global Regulatory Affairs (Submission Project Management) to lead regional and global cross-functional teams. This role involves planning, preparing, and delivering compliant marketing authorization filings, ensuring timely and high-quality submissions for product approvals and lifecycle management. The Director will contribute to submission strategies, provide guidance on regulatory landscapes, and manage project timelines to support the company's mission of advancing novel therapies for obesity and related conditions.

Must Have

• Lead execution of submission strategies in alignment with corporate objectives and regulatory requirements
• Provide guidance on evolving global regulatory landscapes
• Lead and manage cross-functional submission team meetings and workstreams
• Oversee project team delivery of marketing authorization applications
• Liaise with regulatory operations department for submission content plans and compliance
• Develop and manage marketing authorization project timelines and deliverables
• Identify and manage operational risks, implementing mitigation/contingency strategies
• Track progress and report status updates to executive leadership
• Establish best practices and SOPs for marketing application related submission processes
• Ensure adherence to ICH, FDA, EMA, and other global regulatory regulations/guidelines
• Build strong collaborative relationships across departments
• 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
• Collaborated effectively across multidisciplinary teams
• Expertly assessed and mitigated risk within a highly regulated environment
• Strong project management skills
• 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

Good to Have

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

Perks & Benefits

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

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You’ll Do:

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.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• 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

Required Qualifications:

• 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

Preferred Qualifications:

• Experience in international regulatory submissions and regulatory interactions
• Previous regulatory or leadership assignments across multiple countries

Education:

• Bachelor’s degree with regulatory and/or project management experience in the pharmaceutical industry
• Advanced degree in Life Sciences, Regulatory Affairs, or related field (PhD, PharmD, MS preferred)