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Job Ref. ID:  50377 
Job Title: Process Lead - QA/RA
Division: QA Compliance
Work Location: UAE (RAK head office)
Job Type: QA - Process Lead - QA/RA
Employment Type: Full Time Employment (Un-limited Contract)
Job Description:
Purpose: Process Lead – the role holder will support onsite regulatory related review files (New registration, Variation, Renewal, Inquiry response as per updated guideline), including review of all quality related documents, including but not limited to (MFM, FPD, CCF, ECT.). The role holder will review &ensure compliance with current regulatory obligations &Requirements, manage HA circulars’ assessment, maintenance of Vendor per country list execution, support in PV oversight & Regulatory document vendor communication. Quality Technical file preparation as per approved quality standards.
Key responsibilities & Accountability: Key responsibilities & key result areas ● Support global RA functions in RAK, in all regulatory activities, in applying standards for regulatory relevant information. ● Review RA files (New registration, Variation, Renewal, Inquiry response as per updated guideline). ● Perform review of all quality related documents, including but not limited to (MFM, FPD, CCF, ECT) ● Coordinate and respectively prepare timely letters to support registration activities & license maintenance consistent with the agreed HA letters strategy. ● Vendor per Country list: Maintain timely manner update of Vendor per country list as per HAs approval for registration or variation, etc. ● Setup system for tracking of regulatory files/communication review and approval for submissions. ● Vendor per Country list: Daily \Timely manner update of Vendor per country list as per distribution emails related to HAs approval for registration or variation, ect. Periodical posting on Julphar intranet on quarterly basis. Update tracker & list relocation in time. ● Support in following Circular assessment by concerned stakeholders & ensure its Proper assessments, update tracker& Circular Notification relocation in time. ● Oversight all PV related activities for RAK global PV, including but not limited to PSURs, PSMF, ICSRs, RMPs, and RMMs. ● Quality Technical File preparation upon MOHAP request as per approved quality standards. ● Tender\BD questionnaire fulfillment by collecting all relative documents from all concerned stakeholders & compiling for submission. ● Support & address issues related to regulatory compliance checks. ● Solve complex CMC issues related to the product. ● Ability to present and articulate issues for resolution, communicating regularly with key stakeholders to ensure alignment, provide consultation as a scientific/technical resource for raised changes and projects, mentor and share experience with colleagues. ● Act as QA oversight personnel for PV system including quality review and approvals for the relevant documents and HA communications. ● Oversight all PV related activities for RAK global PV. ● Provide regulatory support in view of current Health authority regulatory intelligence information. ● Support local training to build regulatory knowledge as needed to support regulatory compliance at site level ● Support maintenance of effective processes within area of responsibility Core Competency ● In terms of competency you are highly result oriented with strong sense of accountability & ownership. ● Solid Technical knowledge with strong implantation skills ● High on communication and collaboration, having an ability to manage multiple stakeholders at a time ● Must have organizational skills, and planning with proactive oriented attitude in project management. ● In-depth knowledge of the industry's standards and regulations guidelines excellent knowledge of reporting procedures and record keeping ● Must be able to manage tasks and priorities and easily adapt to changing situations. ● Strong communication, interpersonal and negotiation skills as well as capability to influence others in a matrix organization. ● Ability to create cross functional relations and manage conflicts. ● Problem Solving and high agility on taking right decisions
   - Education ● 4 years Bachelor degree in Pharmacy/ Life Sciences /any discipline in same field. ● Master degree in Quality Management is a plus.
   - Experience: ● Total 6 - 8 years of experience pharmaceutical industry preferably in Quality Management systems. And proven experience in Regulatory or pharmacovigilance and distributor management as well. ● Should have handled similar role for better fitment.
   - Training:
Key Competencies: ● Excellent command in English (Communicating, writing and speaking). ● Proficient in MS Microsoft office and computer knowledge.  
Technical Competencies:  


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