Regulatory Affairs Executive

Empower Consulting

Essential/Preferred:

Good communication skills in English: reading, writing, speaking and listening. Other language proficiencies will be added advantage.

Preferable Pharmacy graduate.

Having good knowledge of computers: internet, email, Ms Office (word, excel, PowerPoint and outlook etc.), MS-windows, knowledge of adobe acrobat is desired.

Good communication skills: letters drafting, emails etc.

Min. 6 Months to 1 Year years experience in ACTD / CTD dossier preparation for ROW countries, he/she shall be able to independently prepare and review data required for dossier preparation like AMV, process validation, PDR, Comparative Dissolution Profile & stability data etc.

Co-ordination with manufacturing locations for documents required for dossier preparation and maintains a current updated status of the same.

Document checking and review and coordination with QA, qc and production department.

Ability to review bioequivalence/clinical studies data.

Preparation of DMFs or collection of DMF related data from public sources of information.

Able to handle additional miscellaneous responsibilities like:

1. Communication with factory for obtaining documents, license, COPP, FSC, GMP etc.

2. Scrutinizing the administrative documents from factory.

3. Responsible for the coordination of initiating the process for sample manufacturing it include below:

a) Responsive for getting approval of artworks from the factory.

b) Checking of approval as per regulatory guidelines and Buyer specifications

c) Following up for the arrangement of raw material for samples,

d) Responsible for sending the packing materials and following up with the factory

e) Responsible for taking schedule planning from manufacturing plant for the sample

f) Coordination for the dispatch of finished sample from factory with the coa report.

Request: Someone who can join on immediate.

Experience : 2 - 3 Years

No. of Openings : 2

Education : B.Sc

Role : Regulatory Affairs Executive

Industry Type : Pharma / BioTech / Clinical Research

Gender : [ Male / Female ]

Job Country : India