Job Description

  • Purpose:
  • The position will be based out of Indore and will work on post approval regulatory filings for all markets including compiling supplements/variations, answering queries from regulatory agencies, liaising with the cross-functional teams and manufacturing sites to obtain needful documents for product registration.
  • Position / Job Title - Manager/Sr. Manager
  • Department - Regulatory Affairs
  • Reporting To - GM, Regulatory Affairs
  • Location - Thane
  • Years of Experience - 8-12 years
  • Dosage Form - Any dosage form
  • Job Responsibilities / Deliverables
  • - Preparing and submitting regulatory post approval filings in the US including CBE-0, CBE-30 and PAS supplements as well as Annual Reports and PADERS and similar post approval filings in other countries.
  • Reviewing all submission documentation and authoring dossier sections.
  • Liaising with the cross-functional teams and manufacturing plants for docu...

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