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Regulatory Associate

Navitas Life Sciences
Navitas Life Sciences
Freshers years
Not Disclosed
10 April 26, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

We are looking for a Regulatory Associate. The successful candidate will:

  • Be responsible for publishing, dispatching, and archiving Regulatory Submissions in agency recommended formats
  • Ensure the timely delivery of high-quality Regulatory Submissions following client and internal processes.
  • Prepare submission ready documents for electronic submissions including formatting, hyperlinking, and processing MS Word and Adobe Acrobat documents
  • Develop and maintain up-to-date knowledge of established agency standards and procedures for Regulatory Submissions.
  • Troubleshoot document issues with Adobe Acrobat and MS Word
  • Manage technical aspects for assigned submissions and status updates
  • Collaborate with various departments for planning, preparation, publishing and quality control checks of submissions.
  • Have prior experience and knowledge using various Publishing and Validation tools

Desirable Skills and Experience

  • Experience in Publishing and Submissions is required