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Manager Pharma Drug Products Regulatory Affairs - Pharma DRA API US

10 - 15 yrs
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10,00,000 - 15,00,000 PA. Openings: 1 Posted 6 days ago Job Applicants: 3000+ Job Views: 8000+

Job Description

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    Responsible for preparation & submission of DMF for APIs
    Life cycle management of filed DMFs such as submission of PAS, CBE-0 & CBE-30 & Annual Report.
    Managing compliance issues such as Gap Analysis, Variation / Deficiency / Queries Filing.

Salary: INR 10,00,000 - 15,00,000 PA. Job Location Mumbai Western Suburb Pharmaceutical Company

Industry: Pharma, Biotech, Clinical Research

Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology

Role Category:Drug Regulatory Affairs/Documentation

Role:Regulatory Affairs Manager

Employment Type: Full Time, Permanent


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Desired Candidate Profile

    Manage DRA DMF ANDA API.
    Proven expertise in managing, authoring & submission of eCTD DMF for ANDA for registration of APIs in US markets.
    Life cycle management for successful submission of dossiers & obtaining registration APIs in US Markets..


UG: B.Pharma - Pharmacy

PG:M.Pharma - Pharmacy

Company Profile:

Team Player HR Solutions

A speciality pharma company engaged in the development & manufacture of a comprehensive range of drugs targeting different therapeutic segments customized to each market. The branded generic business is spread in 35+ countries across the globe.
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Job Posted by

Ajai Prakash Sole Proprietor teamplayer hr solutions Mumbai

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