الوصف الوظيفي
United Arab Emirates
Jul 18, 2022
AED 12000 - AED 14000
Contract Full time
Our client is a leading Pharmaceutical company and are looking at hiring experts in Regulatory Affairs and Quality Assurance.
LOC Regulatory and Commercial Quality Expert Ghana dedicates 50% of time for each function.
RA Role.
Act as a RA Expert for the corresponding country, for all Therapeutic Areas (TA)
Support maintenance of marketed products.
Liaison and main contact between LOCs and global groups (Therapeutic Areas teams, CMC teams, Labeling teams, Regulatory Quality teams).
Provide regulatory support for tenders and support daily business and products supply in accordance with our client’s guidelines and local laws & regulations.
CQ Role
The Quality Executive ‘QE’ / Business Quality Expert in Ghana is responsible for the GMP/ GDP Quality of, and meeting the applicable requirements for, the products and services marketed by the Local Operating Company ‘LOC’/ Cluster (including all named-patient materials NPP/ SPR process (what are, product samples).
The QE is also responsible for compliance with the elements of the client’s Quality Policy and QMS that are applicable to the GMP/ GDP activities the LOC/ Cluster undertakes.
This position is also responsible for the continuous improvement of the GMP/ GDP status of the LOC/ Cluster.
The QE is responsible for the oversight of quality and compliance status of all third parties and other client organizations engaged by the LOC/ Cluster for the GMP/ GDP activities for the LOC/ Cluster.
RA Role:
Act as RA Expert for the corresponding country and all TAs:
Provide strategic and valuable RA input to business partners.
Understand Business model and strategy drivers.
Cooperation and partnership horizontally with commercial, MAF and other functions (Govern. Affairs, BQ, Supply chain) as well as with Brand Teams to shape the corporate strategy and create added value.
Act as regulatory representative on project teams and provide advice on specific projects contributing to the development of project plans and target product profiles.
Execute regulatory plans and manage timelines to achieve the stated goals.
Coordinate the preparation, review, submission, Tracking and follow-up of regulatory files (including but not limited to: New MA dossiers, renewals, variations, response to questions) that are properly formatted and in compliance with local regulations.
Prepare local/administrative sections where no local regulatory responsible is designated according to country specific requirements.
Receive, assess completeness/relevance, track and archive core dossiers received from international groups.
Forward all relevant information/data from and in accordance with international groups to LOCs.
Compliance Responsibilities:
Ensure safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOPs (Standard Operating Procedures) are met and, where applicable, appropriately managed when planning projects, developing materials, executing projects and contracting vendors.
Ensure HCC and legal requirements (Fair Market Value, Transfer of Value rules, Promotional Materials rules) are fully understood, appropriately managed and, where applicable, complied when planning projects, developing materials, executing projects and contracting vendors.
المهارات
Regulatory Affairs Specialist
تفاصيل الوظيفة
منطقة الوظيفة دبي, الإمارات العربية المتحدة
قطاع الشركة وكالات التوظيف
طبيعة عمل الشركة صاحب عمل (القطاع الخاص)
الدور الوظيفي التمويل والإستثمار
نوع التوظيف دوام كامل
الراتب الشهري غير محدد
عدد الوظائف الشاغرة 1
https://www.bayt.com/ar/uae/jobs/regulatory-affairs-specialist-4557642/?from_job_search=/ar/jobs/?filters%5Bjb_location_country_iso%5D%5B0%5D=ae&filters%5Bjb_location_country_iso%5D%5B1%5D=kw&filters%5Bjb_location_country_iso%5D%5B2%5D=qa&filters%5Bjb_location_country_iso%5D%5B3%5D=sa&jobId=4529194&options%5Bjb_is_external_job%5D%5B0%5D=1&page=4
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