Officer/sr.officer-regulatory Affairs (APIs)

3 - 4 Years

Job Description

Preparation of CTD format, DMFs, CEPs and their amendments revisions. Prepare response to queries of agencies, customers. Cross checking DMF, analytical and supporting data before submissions. Co-ordination with manufacturing plant.

Required Candidate profile

Knowledge and experience in the field of regulatory APIs. Conversant with current guidelines, regulations, QA. Experience of filing DMFs to overseas agency, CEPs and their amendments. Should have co-ordination, good communication skills.

Salary: INR 2,50,000 - 3,50,000 PA.

Industry:Pharma / Biotech / Clinical Research

Functional Area:Legal, Regulatory, Intellectual Property

Role Category:Drug Regulatory Affairs/Documentation

Role:Regulatory Affairs Manager


Desired Candidate Profile

Please refer to the Job description above


UG:B.Sc - Chemistry

PG:MS/M.Sc(Science) - Chemistry, Any Specialization

Company Profile

Kopran Ltd

An Indian Multinational Pharmaceutical Company with state of the art Plants for the manufacture of Active Pharmaceutical Ingredients and Finished Dosage Forms, having exports to over 50 countries.
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Recruiter Name:Girish Yadav

Contact Company:Kopran Ltd