Global Regulatory Compliance Manager

2 days ago


Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 60,00,000 - ₹ 1,20,00,000

Job Summary:

  • We are seeking a highly skilled Regulatory Affairs Specialist to join our team in ensuring compliance with regulatory requirements for our products, managing the submission process for regulatory approvals, and maintaining up-to-date knowledge of regulatory changes.

Key Responsibilities:

  • Ensure company products comply with relevant regulatory requirements, such as USFDA, FDA, EMA, and local regulations.
  • Prepare and submit regulatory documents, such as INDs, NDAs, and MAAs, to regulatory agencies.
  • Maintain thorough knowledge of regulatory software, including Pharmareddy, eCTD Global, and Educe Solution.
  • Familiarize yourself with filing DMF/Master files/Submissions to countries like Europe/UK, Australia, Brazil, GCC, Jordan, Switzerland, Ukraine, Tunisia, Singapore, and Mexico.


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