Regulatory Affairs Specialist

1 month ago


Ahmedabad, Gujarat, India Lifelancer Full time
Job Overview

Lifelancer is a talent-hiring platform connecting professionals with opportunities in life sciences, pharma, and IT.

Key Responsibilities
  • Facilitate regulatory affairs for solid oral products.
  • Analyze stability data, BPR reviews, and validation reports.
  • Prepare labelling sections for human prescription drugs.
  • Assist in preparing module 32s and 32p sections.
  • Utilize eCTD software for SPL generation and registration.
Requirements
  • Experience with eCTD software (PharmaReddy) for submissions via ESG.
  • Strong knowledge of ANDA regulations, patent and exclusivity, and ICH Q6-A.
  • Hands-on experience with Annual report preparation and Stability data review.
Benefits

This role offers the opportunity to work on various projects and develop expertise in regulatory affairs.

Salary Information

The estimated salary for this position is approximately ₹8,00,000 - ₹12,00,000 per annum based on industry standards and location.



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