Regulatory Affairs Specialist

2 weeks ago


Hawthorne, California, United States Sun Pharmaceutical Industries, Inc. Full time
Job Summary

We are seeking a highly skilled Senior Associate, Regulatory Affairs to join our team at Sun Pharmaceutical Industries, Inc. This role will be responsible for preparing, reviewing, and submitting regulatory documents to the FDA, as well as providing regulatory support for post-marketing commercial activities.

Key Responsibilities
  • Prepare and submit new ANDAs, NDAs, DMFs, and INDs in eCTD format for FDA submission
  • Write related module (Mod 1) in CTD format for NDA, ANDA, DMF, and IND
  • Prepare and submit INDs, NDAs, ANDAs, DMFs, and ANADA annual reports, amendments, and supplements in eCTD compliant format
  • Provide regulatory support for post-marketing commercial activities, including preparing and reviewing supplements (PASs, CBE-30, and CBEs) for FDA submission
  • Evaluate prototype formulations for future filings based on IID database, RLD labeling, RLD patent(s), and exclusivities
  • Prepare Controlled Correspondences for FDA submission based on information provided by R&D department
  • Write SOPs and maintain database
Requirements
  • Three to five years of regulatory experience in the pharmaceutical industry
  • Bachelor's or Master's Degree in a scientific discipline or equivalent
  • Strong written and verbal communication skills
  • Ability to review regulatory and scientific submission documents for accuracy and adherence to regulatory requirements
  • Ability to work effectively in a highly charged, fluid environment
What We Offer
  • Competitive base compensation pay range of $98,000 to $119,500
  • Annual Performance Bonus Plan
  • Employee benefit programs, including medical, dental, and vision coverage, life insurance, disability insurance, 401(k) savings plan, flexible spending accounts, and employee assistance program
  • Paid time off benefits, including vacation time and sick time


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