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Navitas Life Sciences Hiring In Regulatory Affairs

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Navitas Life Sciences Hiring in Regulatory Affairs

About Company

Navitas Life Sciences is seeking a Regulatory Associate – Trainee to join our team. The successful candidate will be responsible for understanding the requirements of various regulatory submissions including IND, ANDA, NDA, and DMF in CTD/eCTD formats for regulatory agencies such as US-FDA, EMA, and Health Canada. Key responsibilities include assisting Regulatory Associates/Senior Regulatory Associates with document-level publishing, including bookmarking, hypertext linking, and preparing Tables of Contents as per the guidelines. The role also involves providing Submission Publishing Support, archiving, and reviewing same-day dispatch, major/complex submissions. Adherence to customer SOPs and policies as well as organizational procedures is essential.

Position Details

Position NameRegulatory Associate – Trainee
OrganizationNavitas Life Sciences
QualificationB.Pharm, M.Pharm, Msc, BSc
Experience0 Years / Freshers
Salary₹25,000 – ₹35,000 per month
LocationChennai

Key Responsibilities

  • Regulatory Submissions: Understand requirements of regulatory submissions (IND, ANDA, NDA, DMF) in CTD/eCTD formats for various regulatory agencies (US-FDA, EMA, Health Canada).
  • Document-Level Publishing: Assist with document-level publishing including bookmarking, hypertext linking, and preparing Tables of Contents.
  • Submission Publishing Support: Provide submission publishing support, archiving, and review of same-day dispatch, major/complex submissions.
  • Compliance: Ensure compliance with customer SOPs and policies as well as organizational procedures.

Desirable Skills and Experience

  • Experience in publishing and submissions is required.

Application Instructions

Interested candidates can apply by sending their resume to recruitment.india@navitaslifesciences.com.


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2 thoughts on “Navitas Life Sciences Hiring In Regulatory Affairs”

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