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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading global labeling activities and developing regulatory strategies for clinical trials and marketed products. Proficient in managing cross-functional teams and ensuring compliance with evolving regulations and documentation standards.
Highest-signal resume keywords
Regulatory LabelingClinical Trial DisclosureLabeling Strategy DevelopmentMicrosoft Office ProficiencyRegulatory Systems Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Global Labeling ActivitiesCore Labeling DevelopmentUS Full Prescribing InformationClinical Trial RegistrationDocumentation Management
Soft Skills
CollaborationRelationship ManagementLeadership
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft OutlookRegulatory Systems
Industry Keywords
Health Authority EngagementRegulatory AffairsLabeling ComplianceClinical Trial DatabasesEvolving Regulations
About the role
Key responsibilities & impact- Lead global labeling activities for development and marketed products
- Lead disclosure activities for applicable clinical trials
- Develop, maintain, and harmonize core and local labeling, including CCDS and TPL
- Lead cross-functional labeling teams developing US Full Prescribing Information and local labeling documents
- Formulate global labeling strategy and support international regulatory colleagues
- Ensure alignment between reference labeling and regional adaptations
- Collaborate on package labeling artwork development, updates, and maintenance
- Support Health Authority interaction labeling strategy, submissions, responses, and negotiations
- Coordinate clinical trial registration, maintenance, redactions, and results posting on clinical trial databases
- Manage individual participant data report generation and external IPD requests
- Maintain relationships with Global Regulatory Affairs teams, cross-functional contributors, and external vendors
- Develop, modify, and execute company policies
- Ensure compliant documentation management and record keeping
- Maintain knowledge of evolving regulations and guidance
- Establish and implement regulatory strategy
- Lead teams through successful Health Authority engagements
Requirements
What you’ll need- BS in related field with 10+ years of related experience
- Experience in Regulatory Labeling and/or Disclosures preferred
- Proficiency with Microsoft Office Applications, including Word, Excel, and Outlook
- Proficiency with regulatory systems
- Candidates must be authorized to work in the U.S.
Benefits
Comp & perks- Comprehensive benefits and work-life resources supporting physical and emotional wellness
- Financial wellness support
- Support for caregivers
- Competitive compensation and benefit package