Associate Director, Global Regulatory Affairs

Kailera Therapeutics

. Serve as the regulatory representative on core teams .

Posted 9/18/2026full-timeRemote • Massachusetts • United StatesSenior💰 $155,000 - $190,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in regulatory submission strategies and compliance within the pharmaceutical industry, with a strong focus on global regulatory guidelines and the integrated drug development process. Proven ability to communicate effectively with stakeholders and manage regulatory risks in a highly regulated environment.

Highest-signal resume keywords

Regulatory Submission StrategiesUS And International Regulatory GuidelinesIntegrated Drug Development ProcessRegulatory ComplianceRisk Assessment And Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsRegulatory IntelligenceClinical Trial RegulationsINDsCTAsNDAsMAAsSOPsWork InstructionsRegulatory Reporting

Soft Skills

TeamworkCommunicationProblem-SolvingAdaptabilityPresentation Skills

Certifications & Qualifications

Bachelor's DegreePhDPharmDMSMBA

Industry Keywords

Pharmaceutical IndustryRegulatory EnvironmentClinical DevelopmentStakeholder CommunicationGlobal Regulatory Guidance

About the role

Key responsibilities & impact

Serve as the regulatory representative on core teams
Develop and plan regulatory submission strategies
Coordinate preparation of submissions to regulatory agencies
Conduct regulatory intelligence activities
Oversee compilation, review, and submission of regulatory applications and submissions, ensuring accuracy, completeness, and timeliness
Monitor the regulatory environment and communicate developments to clinical, regulatory, senior leadership, and other stakeholders
Stay updated on global regulatory guidance and regulations
Communicate key regulatory updates to senior leadership and project team management
Ensure compliance with reporting requirements, including annual and periodic reports
Respond to regulatory questions from authorities in collaboration with clinical development, safety, and other subject matter experts
Provide strategic regulatory guidance for global development and registration programs, including INDs, CTAs, NDAs, and MAAs
Assess and communicate regulatory requirements
Contribute to processes and procedures, including authoring internal work instructions and company SOPs

Requirements

What you’ll need

Demonstrated knowledge of regulatory requirements in the design and conduct of clinical trials, including preparation of regulatory submissions
Established working knowledge of US and international regulatory guidelines and regulations
Demonstrated deep knowledge of the integrated drug development process
Demonstrated ability to find solutions and alternatives through teamwork resulting in positive business outcomes
Demonstrated ability to assess and manage risk in a highly regulated environment
Strong written, spoken, and presentation communication
Strong desire to grow career in the pharmaceutical industry, willingness to learn, and enthusiastically embrace new opportunities
Travel expected (10-15%)
Bachelor's degree with 10+ years of relevant drug development experience OR advanced degree (such as PhD, PharmD, MS, MBA) with at least 5 years of relevant drug development experience

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 insurance
Life insurance
Annual bonus opportunities
Equity grants