Associate, Regulatory Affairs- Labeling
$94,500–$105,000 year
On-siteAll, Catalunya, Kingdom of Spain
All, Catalunya, Kingdom of SpainOn-siteFull Time$94,500–$105,000 yearEntry LevelBachelors DegreeEnterprise
Full TimeEntry LevelBachelors DegreeEnterprise
Job Summary
Prepare regulatory labeling submissions for ANDA dossiers, including reviewing documents for deficiencies and submitting updates to the FDA. Initiate Artwork Approval Sheets via the AMS system, prepare Drug Listings for new and private label products, and revise SPLs for Rx and OTC revisions. Monitor FDA websites for labeling revisions, track labeling summaries for annual reports, and manage documents for approved products and life cycle management. Assist with New Product Information and Master Text preparation for OTC launches. Travel between Princeton and Hawthorne locations may be required.
Required Qualifications
- Bachelor's degree, in scientific field
- 1-3 years of regulatory experience in the generic pharmaceutical industry
- Advanced computer skills
- Solid writing and communication skills
- The ability to work independently in preparation of regulatory documents and correspondence
- Travel between Princeton and Hawthorne location
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