Sr. Exe

2 weeks ago

Ahmedabad, India Zydus Lifesciences Ltd, Ahmedabad Full time

Job Responsibilities:

Overall Responsibilities:

  1. Compiling all the relevant information necessary to prepare best regulatory dossier (M1 to M5) for registration of a new vaccine or a license update in all concerned row countries including WHO Prequalification.

  2. Developing and maintaining the Regulatory Dossier Module 1 to Module 5 keeping the document updated throughout the life of the project/product. Ensuring the coordination with the different areas concerned: Clinical Development, Product Development, Marketing and CMC related functions.

  3. Participating and performing change control assessment (CCRs) of any necessary changes and implementation plan with a global view for the impacted product(s). Filing of relevant Post approval Change (Variation).

Primary Responsibilities:

  • Marketing Authorization Applications (Preparation of dossiers for registration in ROW countries in CTD/ACTD/eCTD)
  • Application for Post Approval Change(s)/Renewal
  • Maintenance of Documentation Data base available with vaccine IRA.
  • Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution and Marketing.
  • Review of Pack Profiles.
  • Review of Artworks (Labels and Package Insert).
  • Preparation / compilation of technical documents related to tenders / queries.
  • Arranging Samples required for registration

Secondary Responsibilities:

  • To ensure continuous improvement in the quality of registration documents, internal systems and processes.
  • Responsible for notification to relevant functional areas and impacted project team(s) regarding communications/feedback from regulatory authority
  • Vaccine Regulatory Intelligence, Sharing vaccine regulatory updates.

Profile Preference:

  • Masters degree in Microbiology/ Biotechnology/Pharma
  • Experience in R&D or Quality Assurance or Quality Control of vaccine & Biologicals shall be considered
  • Proficient in MS Word, Excel, PDF, PowerPoint
  • Experience in preparation of regulatory responses.
  • Strong written and verbal communication skill
  • Strong organization skills
  • Strong Regulatory knowledge and demonstrated application shall be very helpful
  • Strong background in biologics/vaccine/drug development, manufacturing, or testing
  • Demonstrated ability to work successfully on global project teams.

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