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Associate, Regulatory Affairs

4 months ago

Hawthorne NY United States Sun Pharma (Taro Pharma) Full time

The Associate, Regulatory Affairs - Labeling position is responsible for the preparation of various regulatory Labeling submissions.

 

Area of Responsibility:

 

  1. Review and timely completion of labeling for ANDA dossiers for submissions and prepare and review response to labeling deficiencies to secure approval.
  2. Prepare and submit updated labeling in eCTD format to the FDA
  3. Review labeling revisions for Taro and private label products.
  4. Initiate and provide approval for Artwork Approval Sheets for commercialization of artworks through Artwork Management System (AMS).
  5. Convert Taro labels and customers labels to SPL.
  6. Prepare Drug Listings for newly approved and private label products and resolve returned listing problems.
  7. Reserve NDC numbers for Taro and customer labeling.
  8. Monitor FDA web sites for revisions to labeling for RLD of Taro products.
  9. Assist with customs release inquiries.
  10. Track and advice of all labeling revisions for incorporation into annual reports.
  11. Respond to requests for information regarding marketed prescription and OTC products.
  12. Maintain documents on approved and newly filed products.
  13. Electronically search for new regulatory guidelines and regulations.  Perform routine monitoring of Federal Register.
  14. Assist with review, approval and submission of Promotional Materials for Taro Products.
  15. Assist with projects such as FDA inspection, teleconferences arranging webinars, etc.
  16. Collect information to assist in compiling departmental budget.

 

Education and Job Qualifications:

 

  • Bachelor's degree, in scientific field preferred.
  • Minimum 1-3 years regulatory experience in the generic pharmaceutical industry.
  • Advanced computer skills required.
  • Solid written 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 $67,000 to $82,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. 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.