Senior Regulatory Labeling Specialist

Par Health, Inc.; Hazelwood (MO); On-site; USD 90,000 - 130,000; Full time

Job summary

Par Health, Inc. is seeking a Regulatory Affairs Labeling Senior Associate to lead review and approval of regulatory labeling texts for updates across Par sites.

The role demands strict adherence to procedures to ensure error-free labeling and FDA submissions, reporting to the Labeling Director. Qualified candidates will have 4–6 years labeling experience, deep knowledge of SPLs, FDA guidelines, and experience with Veeva Vault and related labeling systems.

Qualifications

• Bachelor’s degree or equivalent experience.
• 4–6 years labeling experience in the pharmaceutical industry.
• Broad based pharmaceutical industry knowledge (Regulatory, Manufacturing, Quality Assurance, Supply Chain, Marketing).
• Strong knowledge of labeling regulations and FDA submission documents.

Responsibilities

• Coordinate labeling development, reviews, and approvals through the RA labeling group.
• Proofread and review proofs for labeling components for all Par sites, Third Party and special projects.
• Review NDA, ANDA and post-approval submissions for labeling revision verification.
• Review the Labeling section of NDA and ANDA Annual Reports.
• Review all Brand and Generic SPL documents for Regulatory Labeling Submissions.
• Labeling workload distribution across projects (50%, 35%, 15%).
• Provide support to internal departments, customers and vendors pertaining to labeling requests.

Skills

Planning/Organizing

Quality

Oral Communication

Written Communication

Education

Bachelor’s degree or equivalent

Tools

Veeva Vault

SPL software

Electronic labeling management system

Job description

Par Health, Inc. is seeking a Regulatory Affairs Labeling Senior Associate to lead review and approval of regulatory labeling texts for updates across Par sites.

The role demands strict adherence to procedures to ensure error-free labeling and FDA submissions, reporting to the Labeling Director. Qualified candidates will have 4–6 years labeling experience, deep knowledge of SPLs, FDA guidelines, and experience with Veeva Vault and related labeling systems.