Regulatory Labeling Associate Director

Lifelancer

. Execute strategic labeling for one or more products at the global label level or across multiple ROW countries/regions .

Posted 9/16/2026full-timeRemote • Massachusetts • United StatesSenior💰 $161,600 - $242,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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

Demonstrates expertise in global labeling compliance and regulatory affairs, with a strong focus on developing and maintaining product labeling in accordance with international standards. Capable of leading cross-functional teams and managing stakeholder interactions effectively.

Highest-signal resume keywords

Global Labeling RequirementsRegulatory Affairs ExperienceLabeling ComplianceFDA and EMA KnowledgeAdvanced Project Management

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

Regulatory Labeling FrameworksLabel DevelopmentCCDS ManagementHealth Authority InteractionsLabeling Strategy Development

Soft Skills

Team LeadershipStakeholder AdvisingPlanning and Prioritization

Tools & Technologies

AI-Driven ToolsAutomation Technologies

Industry Keywords

Life SciencesRegulatory ComplianceGlobal MarketsPreclinical DataClinical Data

About the role

Key responsibilities & impact

Execute strategic labeling for one or more products at the global label level or across multiple ROW countries/regions
Ensure compliance with labeling governance requirements and associated business processes
Lead label working groups
Represent labeling at senior labeling governance meetings
Develop and maintain global product labeling, including company core datasheets, major-market labels, ROW market-specific labels, packaging components, and target label profiles
Contribute to labeling strategy
Advise stakeholders on regulatory labeling requirements for quality, preclinical, and clinical data
Oversee health authority interactions regarding labeling across products or ROW markets
Manage responses to questions, negotiations, and inspections
Potentially take responsibility for specific business processes
Potentially develop and manage a TLP with guidance

Requirements

What you’ll need

Bachelor’s degree, preferably in a life sciences field
Typically 8 years of experience in regulatory affairs in global labeling or a related discipline, or equivalent combination of education and experience
Specialized knowledge of global labeling requirements
Knowledge of development and life-cycle management of CCDS
Knowledge of global regulatory authorities, including FDA and EMA; may include Health Canada and TGA
Advanced ability to develop, use, and apply regulatory global and/or regional labeling frameworks
Advanced ability to plan, prioritize, lead, and execute regulatory labeling work, teamwork, and projects
Strong understanding of labeling compliance and operational requirements
Ability to adopt and leverage emerging technologies, including AI-driven tools
Continuous learning mindset and awareness of technology, AI, automation, competitive intelligence, and regulatory changes

Benefits

Comp & perks

Annual bonus eligibility
Annual equity awards
Medical benefits
Dental benefits
Vision benefits
Generous paid time off
Week-long company shutdown in the Summer
Week-long company shutdown in the Winter
Educational assistance programs
Student loan repayment
Commuting subsidy
Matching charitable donations
401(k)
Remote work five days per week option
Hybrid work option
On-site work option with ad hoc flexibility