Job Ref. ID:
UNITED ARAB EMIRATES
UAE (RAK head office)
Regulatory Affairs - Assistant Manager
Full Time Employment (Un-limited Contract)
The role will adhere with the cGMP principles and to maintain them in an effective manner. He/she will be leading and managing the company compliance project to alight the registered dossier information with the current plant documentation (Product Remediation).He/she will be responsible for handling and managing change control process (impact assessment, variation planning and submission), leading the CAPA's deviations and nternal Audits, assisting the Liaison Team for the assessment of needed variations to set up a strategic submission plan, assisting the variation team for post approval changes (variations) & related queries from Health Authorities, & assisting the review team in variation files revision before dispatching to Liaison Team.
Key responsibilities & Accountability:
-Follows SOPs and recent guidelines for optimal compliance of all products registered for Julphar.
-Determines the action plan based on periodic meeting with related stakeholders for products compliance and documents alignment of registered products in UAE.
-Liaises with multiple stakeholders to arrange all documents required for variation submission in COO.
-Responsible for evaluation of variation packages received from stakeholders for products compliance in COO and ensuring variation submissions and approval to UAE-MOH.
-Responsible for regulatory impact assessment for change controls initiated from RA and other stakeholders, and determining submission plan based on assessment and specific country requirements.
-Responsible for follow up with RA Team to close raised CAPAs and Deviations, managing the internal audits.
-Assists the Liaison Team in planning and strategy preparation of all related variations to UAE-MOH and to all other markets after approval from COO through periodic discussion for monthly plan and products prioritization.
-Provides support and guidance for variation team on notification files and additional inquiries compilation and submission to different markets as and when required.
-Responsible for assisting in variation files assessment and review before dispatching to liaison team to assure conformance of submitted data within given timeline.
-Reviews of MFM received based on Technical Operation Production Plan.
-Responsible for the preparation of Variation status as requested from different stakeholders.
-Performs other related duties/additional tasks as required by management.
-Must have degree in Pharmacy
-Minimum of 8 years' experience pharmaceutical industry is required.
-Excellent written and verbal communication skills.
-Time management and leadership skills.
-Good knowledge of MS Office (Word, Excel, Powerpoint), Adobe PDF, eCTD Software (Pharma ready).
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