Secteur: santé / paramédical / optique
Taille: Entre 20 et 100 employés
Description de l'annonce:
A Pharmaceuticals laboratory is looking to recruit Regulatory Affairs Specialist, Labeling
WHAT YOU’LL DO
Creates and/or revises direct product labeling according to the requirements in domestic and international standards and regulations.
Interfaces with vendors and internal graphic designers to obtain and approve artwork files and proofs.
Assists with review of advertising and promotional labeling to ensure compliance with product claims.
Participates in product development projects and post-market projects as extended team member specializing in labeling.
Organizes and maintains hard copy and electronic department files, as needed.
Adds and maintains labeling information contained in Regulatory Registration Lists and the Global Regulatory Information Database, as needed
Assists in the maintenance of Labeling standard operating procedures, desktop instructions, templates, and forms.
Performs other duties and projects as assigned.
Bachelor’s degree (BS/BA) in a scientific or technical discipline or equivalent experience
One or more years of experience in Regulatory Affairs.
- Ability to work independently, as well as within a team.
- Ability to work on multiple projects simultaneously.
- Demonstrated written and verbal communication skills.
- Good knowledge of product labeling and related requirements
- Proficient with Microsoft Office