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Labeling Pharmaceutical Regulatory Associate Jobs

NJ · On-site

The position will also assist in labeling for new products, changes to labeling for existing ... pharmaceutical regulatory affairs (mandatory) Attention to detail Excellent oral and written ...

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Labeling Pharmaceutical Regulatory Associate information

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As of Sep 13, 2026, the average hourly pay for labeling pharmaceutical regulatory associate in the United States is $30.53, according to ZipRecruiter salary data. Most workers in this role earn between $17.31 and $39.18 per hour, depending on experience, location, and employer.

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Infographic showing various Labeling Pharmaceutical Regulatory Associate job openings in the United States as of September 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $63,493 per year, or $30.5 per hour.

Senior Regulatory Affairs Specialist

Jersey City, NJ • On-site

Integrated Resources INC
Recruiting and Staffing Services • 51 - 200 employees

Full-time

Re-posted 4 days ago


Job description

Company Description

A Few Words About Us
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

JOB SUMMARY

This will person will be a Regulatory liaison between product development and the regulatory agencies. This position will be responsible for regulatory submissions for new ANDAs and any changes being made to existing products. The position will also assist in labeling for new products, changes to labeling for existing prescription and OTC products. This position will also interact with other departments and cross functional teams both in US and India.

DUTIES & ESSENTIAL JOB FUNCTIONS

Regulatory support of new and existing products including the preparation of ANDAs, supplements, Annual Reports, and responses to FDA deficiency letters/information requests.

Independently manage preparation (in paper or electronic formats (eCTD and SPL)), submission and monitoring progress of FDA review of ANDA's

Communication with functional groups for coordination and preparation of data for submission to FDA 

Manage all Regulatory, Federal and State License requirements

Review change controls for regulatory requirements and according to appropriate regulations and guidance's.

Familiar with Regulatory regulations (e.g. FDA guidance, ICH, 21 CFR etc.)

Review labels as per FDA guidance

Regulatory support in drug listing.


Qualifications

QUALIFICATIONS

BS or MS degree in a scientific discipline, preferably Chemistry, Biology or Pharmacy

1 - 2 years' experience in pharmaceutical regulatory affairs (mandatory)

Attention to detail

Excellent oral and written communication skills

Knowledge of US drug regulatory requirements (mandatory)

REQUIRED

BS or MS in Sciences or Pharmacy

PREFERRED

Experience with eCTD filings

Regulatory Affairs Certification (RAC)


Additional Information

Candidates having generic drugs and oral dosage experience as well as background preferred

Contact

Ricky Bansal

732-429-1925



Integrated Resources logo

About Integrated Resources

Sourced by ZipRecruiter

Integrated Resources Inc (IRI), based in Edison, NJ, US, is an esteemed player in the staffing solutions industry with a credible presence on their official website irionline.com. Notably, IRI provides a range of professional staffing services including contract, contract-to-hire, and direct hire solutions to a wide spectrum of industries such as healthcare, life sciences, manufacturing, financial, insurance, and others. Since its inception, IRI has been committed to delivering top-talent and optimum solutions to meet its clients' diverse needs.

Industry

Recruiting and staffing services

Company size

51 - 200 Employees

Headquarters location

Edison, NJ, US

Year founded

1996