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Regulatory Affairs Manager

Confidential Company

Posted on December 1, 2019

8 - 15 years Doha - Qatar

Master of Pharmacy(Pharmacy), Bachelor of Pharmacy(Pharmacy). Any Arabic National, Any GCC National, Any European National

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Job Description

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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 submissions
5. 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.


Pharma / Biotech / Clinical Research

Desired Candidate Profile

- Must have Bachelors/Masters in Pharmacy qualification with minimum 20+yrs of overall experience of which 8-10 yrs experience in managing the Regulatory affairs team within GCC territories.
- Manage the Regulatory Affairs Department.
- Legalize the status of the existing companies and products with MOH records.
- Coordinate with sales department / S&D in achieving their goal.
- Coordinate with business development department to register new companies and products to expand the business.
- Establish a warm relationship with MOH and principal companies.

Keywords

Regulatory Affairs Manager Drug Regulatory Affairs Pharmacovigilance CTD Dossiers Drug registration MOH NDA Medical Device Herbal Manufacturing site registration

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