Associate Director, Global Regulatory Labeling, Ad Promo

Kailera Therapeutics

. Lead the development, review, and maintenance of U.S.

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

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in U.S. product labeling and regulatory compliance, with a strong focus on FDA guidelines and the integrated drug development process. Proven ability to collaborate across teams and provide strategic regulatory guidance throughout the product lifecycle.

Highest-signal resume keywords

Regulatory Guidelines KnowledgeProduct Labeling ExpertiseFDA Compliance ManagementDrug Development ExperienceStrong Communication Skills

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Product LabelingRegulatory ComplianceRisk AssessmentDrug Development ProcessLabeling NegotiationSOP DevelopmentFDA RegulationsAdvertising Promotion RegulationsMedical Review ProcessE-Verify Eligibility

Soft Skills

TeamworkProblem SolvingPresentation SkillsWillingness to LearnEnthusiasm for Opportunities

Certifications & Qualifications

Advanced Degree (PhD, PharmD, MS, MBA)

Industry Keywords

FD&C ActOPDP GuidancePhRMA CodeCompliancePromotional CommunicationsSafety and Efficacy ClaimsRegulatory Review ProcessIndustry Best PracticesEnforcement ActionsWarning Letters

About the role

Key responsibilities & impact

Lead the development, review, and maintenance of U.S. prescribing information, patient labeling, Medication Guides, Instructions for Use, primary and secondary carton labeling, and promotional labeling
Provide regulatory guidance on product labeling throughout development, registration, launch, and post-approval lifecycle management
Collaborate with clinical, CMC, medical, safety, device engineering, technical operations, and commercial teams
Support labeling negotiations with the FDA and manage implementation of approved labeling updates
Evaluate proposed safety, efficacy, and scientific claims for consistency with approved labeling
Serve as a core member of the Medical, Legal, Regulatory review process and collaborate with the MLR process owner
Ensure compliance with FD&C Act requirements, FDA advertising and promotion regulations, OPDP guidance and enforcement trends, PhRMA Code requirements, and company policies and procedures
Provide regulatory recommendations for compliant and effective non-promotional and promotional communications
Monitor evolving FDA guidance, enforcement actions, warning letters, and industry best practices
Contribute to SOPs, policies, and governance processes

Requirements

What you’ll need

Advanced degree (such as PhD, PharmD, MS, MBA) with at least 5 years of relevant drug development experience including product labeling, or a bachelor’s degree with 10+ years
Established working knowledge of regulatory guidelines and regulations (US and international), particularly product labeling and advertising promotion
Deep knowledge of the integrated drug development process
Ability to find solutions and alternatives through teamwork resulting in positive business outcomes
Ability to assess and manage risk in a highly regulated environment
Strong written, spoken, and presentation communication
Desire to grow a career in the pharmaceutical industry, willingness to learn, and enthusiasm for new opportunities
Travel expected (10–15%)
Bachelor’s degree with 10+ years of experience or advanced degree (such as PhD, PharmD, MS, MBA) with 5+ years of experience
New hires must satisfy 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 insurance
Life insurance
Annual bonus opportunities
Equity grants