الوصف الوظيفي
This is a Contract role under ManpowerGroup
ROLE SUMMARY:
Supporting the regulatory projects and executing timely health authority submissions in the region. Coordinate and liaise with country regulatory managers, global regulatory and BMS partners (primarily of GEM, and RSA and also if required other countries of MEAI Turkey cluster). Provide regulatory support to ensure compliance with the local regulations and uninterrupted access of drugs to patients.
AREAS OF RESPONSIBILITY:
• Coordinate and liaise with Country regulatory managers (primarily of GEM and RSA, also if required other countries of MEAI Turkey cluster).
• Coordinate and liaise with global regulatory and labelling team.
• Coordinate and liaise with BMS partners in South Africa
• Coordinate and liaise with Parexel for mature products
• Preparation of submission ready dossiers/documents for new drug applications and other related regulatory activities (e.g. response to Health Authority (HA) questions) both in paper and in electronic (e CTD) format.
• Preparation of submission ready dossiers/documents for post registration variations and MA license renewals both in paper and in electronic (e CTD) format.
• Prepare and manage label updates for submission to the local HA.
• Ensure timely submissions to HA and follow up for approvals.
• Respond to HA queries and correspondences.
• Liaise with local translator to translate HA approved labeling into Arabic. Coordinate with vendors for labeling requirements and Insert artworks for Middle East.
• Coordinate with local Medical Advisor to proofread Arabic insert.
• Maintain and manage label updates: review labels, maintain labels and update relevant BMS systems/trackers/repositories for compliance with BMS SOP and local regulations.
o Ordering of CPPs
o Request for legalization, notary and apostille
o Sample ordering
o Price certificate forms (for renewals)
o Proofreading
o Comparison Tables
• Track and monitor label update submissions/approvals.
• Initiate PPCCRF forms and coordinate with the Production site for any changes and implementations.
• Coordinate with Global Labeling team/NACC Labeling Specialist and Global Production team for the composition copies and development of artworks.
• Maintain accurately and timely update BMS regulatory systems.
o VERITY
o GAME
o PRISM/CARA
o Regulatory SharePoint/Labeling
o Labeling tracker for GEM, Saudi Arabia, RSA
• Support specific regulatory projects for the region as per need.
• Record product complaints in Trackwise and follow up.
• Electronic archiving of regulatory files, product submission files, correspondences and artworks.
• Collaborate with various cross functional teams at a local/regional/global level
• Attend monthly GRS meeting and track important topics for follow-ups.
• Submit eTime on a monthly basis.
المهارات
QUALIFICATIONS AND BACKGROUND REQUIREMENTS
Educational Requirements
Bachelor degree in Science stream.
Arabic language (spoken and written) is an added advantage.
Professional Work Experience & skills
A minimum of 2 to 3 years of regulatory experience in the pharma industry in ME region.
Regulatory experience in the pharma industry in RSA is an added advantage.
Experience in preparation and submission of electronic CTD
Ability to draft and review technical documents required for regulatory submissions.
Ability to asses and execute BMS regulatory strategies.
Strong critical and logical thinking.
Excellent verbal and written communication skills.
Excellent organization skills, ability to multi-task and detail oriented.
Ability to establish and maintain good working relationships at all levels of the company and with external contacts
تفاصيل الوظيفة
منطقة الوظيفة دبي, الإمارات العربية المتحدة
قطاع الشركة وكالات التوظيف/التوظيف
طبيعة عمل الشركة صاحب عمل (القطاع الخاص)
الدور الوظيفي إدارية
نوع التوظيف
الراتب الشهري غير محدد
عدد الوظائف الشاغرة غير محدد
المرشح المفضل
المستوى المهني متوسط الخبرة
*** تقدم على الرابط التالي : Apply on the following link ***
https://www.bayt.com/ar/uae/jobs/regulatory-affairs-coordinator-for-gem-rsa-3999242/
سجل سيرتك الذاتية الآن مجانا لتتقدم لآلاف الوظائف، وتتواصل مع الآف الشركات (+40 ألف شركة)، فقط أكمل نموذج التسجيل
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