Director, Program Management – Regulatory Submissions

Kailera Therapeutics

. Collaborate with clinical, regulatory, non-clinical, and technical operations teams .

Posted 11/10/2026full-timeRemote • Massachusetts • United StatesLead💰 $192,000 - $235,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive project management expertise in the biotech and pharmaceutical sectors, with a strong focus on leading cross-functional teams and managing global marketing authorization submissions. Proficient in developing integrated plans and ensuring compliance with regulatory requirements while maintaining effective communication and collaboration.

Highest-signal resume keywords

10+ Years Project Management ExperienceGlobal Marketing Authorization SubmissionsCross-Functional Team LeadershipDrug Development UnderstandingProficiency in Project Management Tools

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Project ManagementRegulatory ComplianceMarketing Authorization ApplicationsRisk Identification and MitigationAnalytical SkillsAttention to DetailOrganizational SkillsProblem-Solving SkillsComplex Project ManagementInterpersonal Skills

Soft Skills

CollaborationCommunicationResilienceAdaptabilityAttention to Detail

Tools & Technologies

SmartsheetMS ProjectExcelThink-CellOnePager

Industry Keywords

BiotechPharmaceuticalLife SciencesNDABLAMAAClinical OperationsRegulatory AffairsProject PlansSOPs

About the role

Key responsibilities & impact

Collaborate with clinical, regulatory, non-clinical, and technical operations teams
Lead regional and global cross-functional teams in planning, preparing, and delivering compliant marketing authorization filings
Oversee project plans from initiation to completion, ensuring delivery on time, in scope, and within budget
Identify potential risks and implement effective solutions
Lead execution of submission strategies aligned with corporate objectives and regulatory requirements
Lead and manage cross-functional submission team meetings and workstreams across Regulatory, Clinical, Quality, CMC, and Medical Writing
Oversee project team delivery of marketing authorization applications
Develop and own integrated marketing authorization plans covering goals, deliverables, timelines, and resources
Monitor project progress and provide regular updates to the Program Leader and stakeholders
Own program reports and dashboards for executive and governance teams
Establish best practices and SOPs for marketing application submission processes

Requirements

What you’ll need

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
Experience managing cross-functional teams and complex projects in late-stage drug development
Experience managing global marketing authorization submissions (NDA, BLA, MAA) preferred
Demonstrated project management and interpersonal skills
Excellent problem-solving, organizational, attention-to-detail, and analytical skills
Ability to manage multiple priorities in a fast-paced, dynamic environment
Comfortable navigating ambiguity and driving clarity
Ability to maintain composure, resilience, and an open mind while embracing change
Proven record of collaboration and excellent communication
Proficiency in project management tools such as Smartsheet, MS Project, Excel, think-cell, and OnePager
Bachelor’s degree in science, engineering, or a related field; advanced degree preferred
Employment eligibility verification through E-Verify

Benefits

Comp & perks

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