09 Oct

Gcc Fda Regulatory Compliane Consultant Specialist Jobs Vacancy in Gig Drug Store Dubai

Position
Gcc Fda Regulatory Compliane Consultant Specialist
Company
Gig Drug Store
Location
Dubai DU
Opening
09 Oct, 2018 30+ days ago

Gig Drug Store Dubai urgently required following position for Gcc Fda Regulatory Compliane Consultant Specialist. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.

Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.

Gcc Fda Regulatory Compliane Consultant Specialist Jobs Vacancy in Gig Drug Store Dubai Jobs Details:

Gulf interglobal, a dynamic growth oriented company based in Dubai, is seeking a motivated US FDA Regulatory compliance consultant having a demonstrated experience in providing assistance for reviewing product registration files to ensure that all technical documentation complies with GCC and/or US FDA regulatory requirements and/or regulations.

In this role you will :

Technical consulting

  • Provide necessary technical guidance for queries related to ANDA and product registration files compilation in order to meet respectively the requirements as per US FDA and GCC .

ANDA/product registration files review

  • Review of dossier for ANDA/product registration files

Ø Module 1:Guide ectd format

Ø Module 2&3:review of CTD in eCTD format

Ø Module 5:review of BE study or biowaiver

Ø Review of product labeling in compliance with US FDA and/or GCC requirements

Assistance with eCTD submission.

Pre-requisites

An engineer /Pharmacist having a consolidated pharmaceutical regulatory affairs experience in US FDA and GCC regulations and guidelines

Proficient English language skills in regulatory and pharmaceutical/scientific field.

Job Types: Full-time, Part-time, Temporary, Internship, Contract

Location:

  • Dubai (Preferred)


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