
Regulatory Compliance Expert
2 days ago
Job Summary:
- We are seeking a highly skilled Regulatory Affairs Specialist to join our team, responsible for ensuring compliance with regulatory requirements and managing the submission process for regulatory approvals.
Key Responsibilities:
- Regulatory Compliance: Ensure company products comply with relevant regulations such as USFDA, FDA, EMA, and local laws.
- Submission Management: Prepare and submit regulatory documents to agencies like INDs, NDAs, and MAAs.
- Software Knowledge: Familiarity with regulatory software like Pharmareddy, eCTD Global, and Educe Solution.
- Competency: In-depth knowledge of filing DMF/Master files/Submissions to countries like Europe, UK, Australia, Brazil, GCC, Jordan, Switzerland, Ukraine, Tunisia, Singapore, and Mexico.
Required Skills:
- Good understanding of regulatory affairs principles and practices.
- Excellent communication and project management skills.
- Able to work independently and collaboratively in a team environment.
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