Regulatory Labeling Manager, NA, LATAM

ComplianceComplianceFull TimeRemoteTeam 10,001+H1B SponsorCompany SiteLinkedIn

Location

Arizona + 4 moreAll locations: Arizona, Maine, Ohio, Massachusetts, Rhode Island

Posted

47 days ago

Salary

Not specified

English

Job Description

• Review and approve labeling artwork (e.g., cartons, blisters, inserts, and labels) for regulatory compliance, readability, and alignment with approved labeling content • Collaborate with Regulatory Labeling, Regulatory Affairs, Packaging, Quality Assurance, and external vendors to ensure timely and accurate artwork development • Verify that artwork reflects approved applicable information from prescribing information, including dosage, administration, safety warnings, and product identification • Training and oversight of additional FSP resources for artwork management • Ensure compliance with country-specific regulatory requirements, including FDA, EMA, and other global health authorities • Maintain documentation of artwork reviews, approvals, and version control in accordance with SOPs • Participate in cross-functional meetings to support product launches, labeling updates, and change control processes • Support continuous improvement initiatives related to artwork review processes and labeling systems

Job Requirements

  • Strong understanding of regulatory labeling requirements (e.g., FDA, EMA, ICH)
  • Detail-oriented with excellent proofreading and quality control skills
  • Familiarity with artwork management systems (e.g., GLAMS, Adobe Illustrator, Esko)
  • Familiarity with proofreading tools (e.g., TVT, Global Vision)
  • Ability to work independently and collaboratively in a fast-paced environment
  • Strong communication and organizational skills

Benefits

  • Health benefits to include Medical, Dental and Vision
  • Company match 401k
  • eligibility to participate in Employee Stock Purchase Plan
  • Eligibility to earn commissions/bonus based on company and individual performance
  • flexible paid time off (PTO) and sick time

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