Gcc Fda Regulatory Compliane Consultant Specialist Jobs Vacancy in Gig Drug Store Dubai
- Gcc Fda Regulatory Compliane Consultant Specialist
- Gig Drug Store
- Dubai DU
- 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.
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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 :
- 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.
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
- Dubai (Preferred)