Regulatory Affairs, Labeling Lead

Full Time
East Brunswick, NJ, US
Posted 2 months ago

Hybrid role – 3 days in office located in East Brunswick, NJ and 2 days remote.

Job Summary:

The primary responsibility of this position is to prepare, review and approve pharmaceutical labeling for generic drug products.  This includes container labels, cartons, package insert, medication guides etc.  The individual will manage and maintain Labeling for the organization.  The individual is responsible for ensuring Labeling meets FDA requirements and internal timelines.

 Reporting Relationships                                                                                  

 This position has up to 2 direct reports.

 Essential Functions:

  • Create draft labeling for new generic drug product labeling for submission in ANDAs to FDA.
  • Work with multiple printers for creation of artwork and final print labeling. 
  • Create/manage SPL files. Ensure drug listing is up to date and accurate.
  • Initiate changes for labeling as required.
  • Ensuring annual drug listing certifications are completed accurately and in accordance with FDA stipulated timeframes. 
  • Initiate Change Control for labeling changes
  • Review and approve labeling for submission and for printing as required.
  • Ensure labeling is up to date with current Reference Listed Drug Labeling
  • Manage process of implementing new labeling as needed.
  • Ensure complete and accurate Regulatory files for Labeling.
  • Establish standards for Labeling preparation and review.
  • Adhere to all safety and cGMP standards and guidelines, and report unsafe conditions, near misses, and/or injuries in a timely manner.
  • All other duties assigned by Manager.

Specialized Skills and Knowledge:                                                                                  

  • BS/BA degree preferred but not required or equivalent experience
  • Minimum 2 years Regulatory Affairs Labeling experience 
  • Generic drug labeling experience required
  • Knowledgeable in FDA Labeling requirements
  • Prior use/knowledge of GlobalVision preferred but not required

Key Competencies:

1. Ability to communicate effectively 

2. Detail oriented 

3. Highly organized

4. Ability to work on multiple projects at a time

5. Efficient in word, adobe, excel, and SPL (Xforms and/or CDER Direct) 

Physical Demands/Factors:

Work is primarily sedentary in nature; routine bending, walking, lifting and reaching are required.

At Avet, we require that all employees physically entering the workplace to be fully vaccinated against COVID-19, and you will be asked to present proof of vaccination before beginning employment unless you qualify for a reasonable accommodation based on a sincerely held religious belief or medical need.

Based on the highly regulated workplace at Avet, employees will be required to meet minimum English proficiency requirements.

 Avet is proud to be an Equal Opportunity Employer.

All applicants must be legally authorized to work in the U.S. for any employer.  We are unable to sponsor any applicants for a work visa or take over sponsorship of a work visa for any applicants, at this time.

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.

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Job Features

Job CategoryManufacturing, Regulatory Affairs

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