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Drug Regulatory Affairs ANDA

Mumbai, Maharashtra

AMY Pvt Ltd

Job Description

Designation: Asst Executive DRA
Job Location: Kandivali
Qualification: B.Pharma/M.Pharma
Expierence: 4 yrs & Above
Salary: As per industry std.
Description:
-Handling filing of ANDA for USFDA.
-Review of formulation related documents like PDR (as per QBD concept), BMR, BPR, stability protocols & Stability Data.
-Handling post approval changes, PAS and supplement filing.
-Handling query responses submission
-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 department, formulation development, manufacturing location for revision of Specification and standards test procedure.

Company Description

AmyPvt. Ltd which is an ISO 9001 – 2008 certified company.
H R Management Services...   Read full description

Additional Information

Last updated:
24/10/2017
Job type:
Full time
Position type:
Permanent
Vacancies:
6
Minimum experience:
Between three and five years
Education:
Compulsory Education
Salary range:
₹ 3,50,000 - ₹ 6,00,000 / Yearly (Gross Pay)
Category:
Jobs in Pharma, Biotech and Chemical Industry
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