Job Description:

  • 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

Salary: Negotiable

Contact Details:

APPLY ONLINE

 

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