Regulatory Affairs Specialist

11 hours ago


Mumbai, Maharashtra, India Lifelancer Full time

Established in Vikhroli West, Lifelancer is a leading talent-hiring platform connecting professionals with opportunities in pharma, biotech, health sciences, and IT domains.

We are seeking a highly motivated Regulatory Affairs Trainee to join our team. As a Regulatory Affairs Trainee, you will be responsible for preparing, compiling, and coordinating regulatory documents for the ROW market.

Key Responsibilities:

  • Preparation of Common Technical Document (CTD)/Active Substance Technical Dossier (ACTD) dossiers for ROW markets
  • Coordinating with various departments for relevant documents required for dossier compilation
  • Reviewing documents such as DMF, analytical reports, specification, process validation protocol, report, BMR, COA, PDR, and stability data
  • Handling queries from health authorities for dossiers from various countries

Requirements:

  • Bachelor's or Master's degree in Pharmacy (BPharma/MPharma)
  • Excellent English communication skills

What We Offer:

A competitive salary of Rs. 16,700 to Rs. 17,000 per month, plus company benefits. Under the guidance of a senior officer, you will receive comprehensive training in regulatory affairs.

Join us at Lifelancer and take your career to new heights



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