Senior Pharma Labeling Compliance Specialist

Paladin Labs Inc.; Hazelwood (MO); Hybride; USD 90 000 - 130 000; Plein temps

Résumé du poste

Par Health is seeking a Regulatory Affairs Labeling Senior Associate to lead labeling reviews and ensure FDA compliant submissions across Endo sites. You will work with the labeling team to maintain accuracy and adherence to procedures for all labeling updates.

The role requires strong knowledge of NDA/ANDA processes, SPL, and electronic submission standards within a fast‑paced pharmaceutical environment. On‑site work is expected in a regulated setting with cross functional teamwork.

Qualifications

• Bachelor’s degree or equivalent experience is required.
• 4–6 years of labeling experience in pharma is expected.
• Broad knowledge of pharmaceutical labeling regulations for brand and generic drugs.
• Experience with FDA electronic submission documents is required.
• Strong GMP/SOP knowledge and QA experience.
• Experience using SPL software and Veeva Vault is expected.

Responsabilités

• Coordinate labeling development, reviews, and approvals across RA labeling groups.
• Proofread and review in‑house and vendor labeling proofs for all sites.
• Review NDA/ANDA documents for labeling revisions and compliance.
• Review SPL documents for regulatory submissions across products.
• Support internal teams and vendors on labeling requests and issues.
• Assist with documentation systems/tools implementation and use.

Connaissances

Planning/Organizing

Quality

Oral Communication

Written Communication

Formation

Bachelor’s degree or equivalent experience

Outils

Veeva Vault

SPL software

Electronic labeling management system

Docuproof

Description du poste

Par Health is seeking a Regulatory Affairs Labeling Senior Associate to lead labeling reviews and ensure FDA compliant submissions across Endo sites. You will work with the labeling team to maintain accuracy and adherence to procedures for all labeling updates.

The role requires strong knowledge of NDA/ANDA processes, SPL, and electronic submission standards within a fast‑paced pharmaceutical environment. On‑site work is expected in a regulated setting with cross functional teamwork.