
Global Regulatory Compliance Manager
2 days ago
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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