Opening for : Executive - DRA ANDA ( US Market)

3 - 8 YearsNot Disclosed by Recruiter
Mumbai, Mumbai Suburbs, Thane
Posted: 10 days ago

Job Description


1. Handling filing of ANDA for USFDA. 2. Review of formulation related documents like PDR (as per QBD concept), BMR, BPR, stability protocols & Stability Data. 3. Handling post approval changes,PAS and supplement filinge..

Salary: Not Disclosed by Recruiter

Industry: Pharma / Biotech / Clinical Research

Functional Area: Engineering Design, R&D

Role Category: Drug Regulatory Affairs/Documentation

Role: Drug Regulatory Director

Key Skills

Desired Candidate Profile

UG: B.Pharma - Pharmacy

PG: M.Pharma - Pharmacy

    * Review of Specification, CQA of API, raw material, Packaging material and finished Products.
    *Compilation of Documents as per eCTD requirement for CMC section for module 1 to Module 3 and annual updates.
    * Co-ordination with documentation

Company Profile

We are established in the field of recruitment & manpower providers,We have provided our services to the critical core industries i.e. Chemical, Pharmaceutical, Engineering, Automobile, Construction, Cement/Metal, Trading, IT, Education, BPO & Other
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Contact Details

Recruiter Name:Vrishali

Contact Company:Sai Placement

Reference Id:sai@ANDA