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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in global labeling and regulatory strategies, with a strong focus on developing and maintaining Company Core Data Sheets (CCDS) and ensuring compliance with international regulations. Proven ability to lead cross-functional teams and communicate effectively with stakeholders across diverse settings.
Highest-signal resume keywords
Global Labeling Strategy DevelopmentCCDS Authoring And GovernanceRegulatory Submissions (MAA/NDA/BLA)Cross-Functional Team LeadershipStrong Knowledge Of Global Regulations
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Filings (CTD Format)Medical/Technical WritingLabeling Content DevelopmentLabeling ComplianceOncology Or Rare Disease ExperienceVaccine Development RegulationsLabeling Documentation ManagementHealth Authority CommunicationProject ManagementStrategic Leadership
Soft Skills
Excellent Communication SkillsLeadershipCollaborationRelationship BuildingFlexibility/Adaptability
Tools & Technologies
Veeva RIMSEDMS (Veeva)ApolloDocubridgeTrackwiseMicrosoft OfficeSharePointAdobe AcrobatTVTPromomats
Industry Keywords
Biotech IndustryPharmaceutical IndustryGlobal RegulationsRegulatory ComplianceLabeling ActivitiesHealth Authority ResponsesCross-Functional Product DevelopmentLife Sciences DegreeAdvanced Degree (MSc, PhD, PharmD)FDA/EMA/MHRA Regulations
Tech Stack
Tools & technologiesApollo
About the role
Key responsibilities & impact- Provide strategic leadership and operational oversight for global labeling activities
- Lead Target Product Label (TPL) development for early-stage assets
- Develop and maintain Company Core Data Sheets (CCDS)
- Develop regional labeling strategies and support US, EU, Rest of World, and other major markets
- Develop labeling content, format, and accountability for regulatory submissions, including MAAs, supplements, and amendments
- Ensure new labeling text meets regulatory labeling requirements
- Support Rest of World labeling assessments against the CCDS and prepare Health Authority responses
- Interface with project teams to ensure consistent labeling processes and local compliance with the CCDS
- Communicate regulatory labeling strategy, risks, mitigation strategies, and plans to global leadership, project development teams, and senior management
- Provide input into the end-to-end labeling process
- Lead and manage labeling team meetings, driving strategic discussions and managing content
- Provide coverage for other products during peak periods or team-member absences
- Partner with stakeholders across Regulatory, Clinical, Safety, Medical, and Commercial functions
- Contribute to medical and technical writing, ROW impact assessments, and cross-functional product-development decisions
- Ensure compliant, high-quality labeling documentation throughout the product lifecycle
Requirements
What you’ll need- Bachelor’s degree in Life Sciences or related field required
- Advanced degree (MSc, PhD, PharmD) preferred
- 7-10+ years in biotech/pharmaceutical industry
- 5-7+ years in global labeling/regulatory with global strategic leadership responsibilities
- Proven ability to lead cross-functional teams and influence stakeholders across diverse cultural and geographic settings
- Strong knowledge of current global regulations, including vaccine development regulations and registration pathways
- Previous experience in oncology or rare disease highly preferred
- Strong experience with CTD format and content regulatory filings
- Direct experience authoring, maintaining, and governing CCDS required, including ownership of global labeling updates and coordination of downstream implementation across regional labels
- Delivery of labeling for at least one major application (NDA/BLA/MAA/JNDA, etc.)
- Familiarity with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, and Change Management systems (e.g., Trackwise)
- Experience with Microsoft Office applications, SharePoint, Adobe Acrobat, TVT, Promomats, and GLAMS
- Experience facilitating meetings and driving consensus and results
- Excellent leadership, communication (verbal and written), and collaboration skills
- Proven ability in medical/technical writing
- Experience with TPL work for early development programs and identified life-cycle programs
- Sense of urgency regarding FDA/EMA/MHRA/other health authority communications and response timelines
- Integrity and high standards
- Results orientation and strategic orientation
- Flexibility/adaptability in varied situations and with diverse individuals and groups
- Relationship building, teamwork, and cooperation
- Fluency in English (verbal and written); additional languages are an asset
- Candidates outside the EST time zone must have flexibility to provide coverage during EST hours
Benefits
Comp & perks- Equal opportunity employment consideration
- Opportunity to work across diverse markets and therapeutic areas
- Opportunity to shape global labeling strategy and lead governance processes
- Collaborative, dynamic environment
- Opportunity to contribute to innovative campaigns and improve patient access to accurate product information