Senior Regulatory Labeling Associate — FDA Submissions

Endo; Hazelwood (MO); On-site; USD 90,000 - 120,000; Full time

Job summary

Endo is seeking a Regulatory Affairs Labeling Senior Associate to lead review and approval of labeling text for updates across Endo sites. You will ensure error-free labeling and FDA submissions in a regulated environment.

The role requires coordinating with RA labeling, Graphics, and cross-functional teams to meet critical timelines while maintaining regulatory compliance and quality standards.

Qualifications

• Bachelor’s degree or equivalent experience.
• 4–6 years labeling experience in the pharmaceutical industry.
• Broad based pharmaceutical industry knowledge (Regulatory, Manufacturing, QA, Supply Chain, Marketing).
• Strong knowledge of regulations/guidelines governing labeling of pharmaceutical products.
• Working knowledge of FDA electronic submission documents.
• Knowledge of GMP and SOPs.
• Experience using an electronic document management system (e.g. Veeva Vault).
• Experience with SPL and SPL software.

Responsibilities

• Coordinate labeling development, reviews, and approvals through the RA labeling group.
• Proofread and review proofs for labeling components for all Endo sites and vendors.
• Review NDA/ANDA labeling documentation for revision verification.
• Review Labeling sections of NDA/ANDA Annual Reports.
• Review SPL documents for regulatory labeling submissions.

Skills

Planning/Organizing

Quality

Oral Communication

Written Communication

Education

Bachelor's degree

Tools

Veeva Vault

SPL software

Electronic labeling system

Job description

Endo is seeking a Regulatory Affairs Labeling Senior Associate to lead review and approval of labeling text for updates across Endo sites. You will ensure error-free labeling and FDA submissions in a regulated environment.

The role requires coordinating with RA labeling, Graphics, and cross-functional teams to meet critical timelines while maintaining regulatory compliance and quality standards.