Labeling & Regulatory Submissions Associate

Sun Pharmaceutical Industries, Inc.; Princeton (NJ); On-site; USD 95,000 - 105,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Life insurance

Disability insurance

401(k) savings plan

Flexible spending accounts

Employee assistance program

Annual Performance Bonus Plan

Paid time off

Job summary

Sun Pharmaceutical Industries, Inc. in Princeton, NJ seeks an Associate, Regulatory Affairs- Labeling to prepare and review labeling submissions for ANDAs and ensure compliant labeling across Rx/OTC products.

The role covers preparation of labeling, responses to deficiencies, and submission to the FDA, with travel between Princeton and Hawthorne as required. Strong writing ability and 1–3 years in regulatory affairs in generics are essential.

Qualifications

• Bachelor's degree in a scientific field.
• 1-3 years of regulatory experience in the generic pharmaceutical industry.
• Strong writing and communication skills; ability to work independently on regulatory documents.

Responsibilities

• Prepare labeling for ANDA dossiers and respond to labeling deficiencies.
• Submit updated labeling to the FDA.
• Approve Artwork Submission Sheets for commercialization, via AMS system.
• Prepare Drug Listings for new labels and resolve listing problems.
• Revise SPL for each revision (Rx and OTC).
• Monitor FDA labeling revisions for RLD updates related to ANDAs.
• Track labeling summaries for annual reports.
• Maintain documents for approved and filed products and Life Cycle Management.
• Assist with New Product Information (NPI) data.
• Prepare Master Text for OTC products before launch and ensure alignment with National Brand Equivalent.
• Travel between Princeton and Hawthorne locations as needed.

Skills

Regulatory experience

Education

Bachelor's degree in science

Job description

Sun Pharmaceutical Industries, Inc. in Princeton, NJ seeks an Associate, Regulatory Affairs- Labeling to prepare and review labeling submissions for ANDAs and ensure compliant labeling across Rx/OTC products.

The role covers preparation of labeling, responses to deficiencies, and submission to the FDA, with travel between Princeton and Hawthorne as required. Strong writing ability and 1–3 years in regulatory affairs in generics are essential.