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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory Affairs labeling processes, including proofreading and reviewing labeling components, while ensuring compliance with FDA regulations and Good Manufacturing Practices. Proficient in using electronic document management systems and Structured Product Labeling software to support labeling development and approvals.
Highest-signal resume keywords
Labeling Experience In Pharmaceutical IndustryKnowledge Of FDA RegulationsExperience With Structured Product Labeling (SPL)Proficiency In Electronic Document Management SystemsStrong Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Labeling DevelopmentRegulatory Documentation ReviewStructured Product Labeling (SPL)FDA Electronic Submission DocumentsGood Manufacturing PracticesStandard Operating ProceduresProofreadingQuality AssurancePlanning And OrganizingAccuracy And Thoroughness
Soft Skills
Clear Oral CommunicationGroup Presentation SkillsClear Written CommunicationEditing SkillsInterpretation Of Written Information
Tools & Technologies
DocuproofVeeva Vault
Industry Keywords
Pharmaceutical IndustryRegulatory AffairsManufacturingQuality AssuranceSupply ChainMarketing
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Coordinate labeling development, reviews, and approvals through the Regulatory Affairs labeling group
- Proofread and review in-house and vendor proofs for labeling components across Par sites, third-party projects, and special projects
- Review regulatory documentation for NDA, ANDA, and post-approval submissions to verify labeling revisions
- Review the labeling section of NDA and ANDA annual reports
- Review Brand and Generic Structured Product Labeling (SPL) documents for each Regulatory Labeling Submission
- Prioritize workflow to meet critical timelines aligned with departmental and company objectives
- Collaborate with the Graphics Department on in-house artwork
- Monitor graphic development of labeling components for generic products
- Support internal departments, customers, and vendors with labeling requests, inquiries, issues, and responses
- Support implementation and use of documentation systems and tools, such as Docuproof
- Work with cross-functional team members within Endo and with partner companies
Requirements
What you’ll need- Minimum Bachelor’s degree or equivalent experience
- Minimum 4–6 years of labeling experience in the pharmaceutical industry
- Broad-based pharmaceutical industry knowledge covering Regulatory, Manufacturing, Quality Assurance, Supply Chain, and Marketing
- Strong knowledge of regulations/guidelines governing labeling of pharmaceutical products for brand and generic drugs
- Working knowledge of FDA electronic submission documents
- Strong knowledge and understanding of current Good Manufacturing Practices and Standard Operating Procedures
- Experience using an electronic document management system, such as Veeva Vault
- Experience developing Structured Product Labeling (SPL) and using SPL software
- Planning and organizing skills
- Accuracy and thoroughness in quality-focused work
- Clear oral communication and group presentation skills
- Clear written communication, editing, and interpretation of written information