Title:  Associate, Regulatory Affairs- Labeling

Job purpose

This role is responsible for the preparation of various regulatory Labeling submissions and as well as review of labeling documents for submission.

Duties and responsibilities

1. Preparation and timely completion of labeling for ANDA dossiers for Labeling submissions and prepare and review response to labeling deficiencies to secure approval.
2. Prepare and submit updated labeling to the FDA
3. Initiate and provide approval for Artwork Approval Sheets for commercialization of artworks through Artwork Management System (AMS) for commercial products.
4. Prepare Drug Listings for newly approved labels and private label products and resolve returned listing problems.
5. Ensure to revise SPL for each revision to (Rx and OTC)
6. Routine Monitoring of FDA web sites for revisions to labeling for RLD Updates corresponding to our ANDAs.
7. Track and prepare labeling summary for incorporation into annual reports.
8. Maintain documents on approved and newly filed products and also Life Cycle Management.
9. Assist with the completion of information for New Product Information (NPI)
10. To assist with preparation of Master Text for OTC products before launch and work on timely revisions to ensure they are in line with the National Brand Equivalent. Ensure proper reposition of Master Text for all OTC products.
11. Other duties as assigned
12. Travel between Princeton and Hawthorne location may be required, as defined by business needs

Qualifications

• Bachelor's degree, in scientific field.
• 1-3 years of regulatory experience in the generic pharmaceutical industry.
• Advanced computer skills required.
• Solid writing and communication skills and the ability to work independently in preparation of regulatory documents and correspondence.

The presently-anticipated base compensation pay range for this position is $94,500 to $105,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.