- Leading and Guiding Team of Regulatory affairs.
- Able to Explain Regulatory strategy during Development.
- Ensuring that the Development of Products is in accordance to FDA guidelines any concerns need to be outlined to sr RA Leaderships.
- Coordination with various stakeholders to get the right documents and timely submission.
- Escalate issues which can delay submissions, can cause RTRs or result in suboptimal submissions
- Reviewing Dossiers after compilations to maintain quality of Submissions.
- Performing regulatory activities as directed by Management.
- Provide Regulatory support to the Development site.
- Reviewing and Supporting ANDA documentation to ensure compliance with FDA requirements, to prevent any RTRs.
- Highlight any regulatory issues or concerns during development
- Development Support (New Submission).
Qualification: M. Pharma
Experience: 10-12 yrs in DRA