Associate, Regulatory Affairs- Labeling

About the role

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

Responsibilities

• Prepare and complete labeling for ANDA dossiers for Labeling submissions and prepare and review responses to labeling deficiencies to secure approval.
• Prepare and submit updated labeling to the FDA.
• Initiate and provide approval for Artwork Approval Sheets for commercialization of artworks through Artwork Management System (AMS) for commercial products.
• Prepare Drug Listings for newly approved labels and private label products and resolve returned listing problems.
• Revise SPL for each revision to Rx and OTC products.
• Routinely monitor FDA websites for revisions to labeling for RLD updates corresponding to ANDAs.
• Track and prepare labeling summaries for incorporation into annual reports.
• Maintain documents on approved and newly filed products and Life Cycle Management.
• Assist with the completion of information for New Product Information (NPI).
• Prepare Master Text for OTC products before launch and ensure timely revisions align with the National Brand Equivalent.
• Ensure proper repositioning of Master Text for all OTC products.
• Perform other duties as assigned.
• Travel between Princeton and Hawthorne locations may be required, as defined by business needs.

Requirements

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

Pay

The presently-anticipated base compensation pay range for this position is $94,500 to $105,000. Actual base compensation may vary based on factors including but not limited to geographical location and experience.

Benefits

• Medical, dental, and vision coverage.
• Life insurance and disability insurance.
• 401(k) savings plan.
• Flexible spending accounts.
• Employee assistance program.
• Paid time off benefits, including vacation time and sick time.
• Participation in the Annual Performance Bonus Plan.

The compensation and benefits described 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 eligibility terms.