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Regulatory Affairs Manager

8.00 to 15.00 Years   Doha - Qatar   18 Dec, 2019
Job LocationDoha - Qatar
EducationMaster of Pharmacy(Pharmacy), Bachelor of Pharmacy(Pharmacy).
SalaryNot Mentioned
IndustryPharma / Biotech / Clinical Research
Functional AreaNot Mentioned

Job Description

A leading Pharmaceutical distribution company is recruiting a Regulatory Affairs Manager for its Qatar office.Responsibilities:1. Communicate with principal companies for gathering of information, and review of documents for Regulatory submissions of NDA, Medical Device, Herbal, Manufacturing site registration and their renewal, minor variations. 2. Evaluate documents for submissions to assure accuracy, compliance with MOH regulatory requirements.3. Plan and prioritize the regulatory submissions.4. Work closely with Regulatory team to solve critical issues related to regulatory submissions5. Collect circulars and update the records on MOH regulatory procedures changes and keep informed the principal companies on the same. 6. Provides updates to revised regulations/guidance documents to principal companies and assess impact to the organization. 7. Recommend strategies for earliest possible approvals of regulatory submissions and quality control lab clinical analyses. 8. Develop and supervise tracking/control systems for regulatory submission activities to ensure timelines and commitments are met.

Keyskills :
Regulatory Affairs Manager

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