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Regulatory Affairs Labeling Jobs in Basking Ridge, NJ

MTF Biologics

Manager, Regulatory Affairs

Edison, NJ · On-site +1

$125K/yr

This role oversees Regulatory Affairs personnel and ensures effective execution of U.S. and ... licensing, labeling and promotional review, quality system documentation, risk management, and ...

MTF Biologics

Manager, Regulatory Affairs

Edison, NJ · On-site +1

$125K/yr

This role oversees Regulatory Affairs personnel and ensures effective execution of U.S. and ... licensing, labeling and promotional review, quality system documentation, risk management, and ...

MTF Biologics

Manager, Regulatory Affairs

Edison, NJ · On-site +1

$125K/yr

This role oversees Regulatory Affairs personnel and ensures effective execution of U.S. and ... licensing, labeling and promotional review, quality system documentation, risk management, and ...

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How much do regulatory affairs labeling jobs pay per hour?

As of Aug 25, 2026, the average hourly pay for regulatory affairs labeling in Basking Ridge, NJ is $40.78, according to ZipRecruiter salary data. Most workers in this role earn between $32.69 and $48.32 per hour, depending on experience, location, and employer.

What is a regulatory affairs labeling?

A Regulatory Affairs Labeling job involves ensuring that product labeling complies with regulatory requirements set by health authorities such as the FDA, EMA, or other global agencies. Professionals in this role develop, review, and manage labeling content, including packaging inserts, patient information, and safety warnings. They work closely with cross-functional teams, including regulatory, clinical, and marketing, to ensure accuracy and compliance. Their responsibilities also include tracking regulatory updates and implementing necessary label changes to meet evolving guidelines.

What are some typical challenges faced in a regulatory affairs labeling role?

Professionals in Regulatory Affairs Labeling often face the challenge of keeping up with frequently changing global regulations and ensuring all product labeling remains fully compliant. Managing tight deadlines while coordinating with cross-functional teams—such as clinical, legal, and marketing departments—can also be demanding. Additionally, interpreting complex regulatory language and translating it into clear, accurate, and user-friendly consumer information requires both technical acumen and attention to detail. Adaptability and proactive problem-solving help professionals excel in overcoming these challenges.

What are the key skills and qualifications needed to thrive in regulatory affairs labeling, and why are they important?

To thrive as a Regulatory Affairs Labeling professional, you need thorough knowledge of regulatory guidelines, strong analytical skills, and experience in pharmaceutical or medical device labeling. Familiarity with document management systems, regulatory submission software, and certifications like RAC (Regulatory Affairs Certification) are often advantageous. Attention to detail, excellent communication, and strong organizational skills are key soft skills for success in this position. These abilities are essential to ensure labeling materials are accurate, compliant, and consistently meet evolving regulatory requirements.

What are popular job titles related to Regulatory Affairs Labeling jobs in Basking Ridge, NJ?

For Regulatory Affairs Labeling jobs in Basking Ridge, NJ, the most frequently searched job titles are:

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Regulatory Affairs Labeling jobs near you
Infographic showing various Regulatory Affairs Labeling job openings in Basking Ridge, NJ as of August 2026, with employment types broken down into 100% Contract. Highlights an 100% In-person job distribution, with an average salary of $84,822 per year, or $40.8 per hour.

Associate, Regulatory Affairs- Labeling

Sun Pharmaceutical Industries

Princeton, NJ • On-site

$94K - $105K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 8 days ago

Job description

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.

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