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Job Ref. ID:  50541 
Job Title: Team Leader
Division: REGULATORY AFFAIRS
Country: UNITED ARAB EMIRATES
Work Location: UAE (RAK head office)
Job Type: Team Leader
Employment Type: Full Time Employment (Un-limited Contract)
Job Description:
Purpose: Responsible for compilation and submission of new registration dossiers to respective countries as per the registration plan  Handle the queries by providing the appropriate responses, as it is required to get the approvals from the health authorities of different countries.  Evaluation and identification of documentation gaps during the dossier compilation and communicating with the respective department to fulfil requirements.
Key responsibilities & Accountability: Prepare the Registration dossiers for the Health authorities in different countries as per their current guidelines.  Provide responses for the queries received from the Health authorities:  Coordinate with the Regulatory agents in countries, distributor and other concerned departments in order to fulfil the registration requirements.   Update product specific APQR sheet which comprises of complete approved information related to product at the time of the approval in the related market.  Ensure compliance with submission/approval annual plans  Ensure that all state and International regulatory requirements are addressed for the marketed products and New Product submission.  Lead to provide the Document Management Guidelines in support private markets for different entities.  Maintains knowledge of the current regulatory guidelines environment by reviewing and communicating current decrees policies/practices issued by Health Ministry.  Creates and builds confidence by representing the excellent strategic function of the Company positioning as a preferred source for regulatory strategy expertise. Core Competency  In terms of competency you are highly result oriented with strong sense of accountability & ownership.  High on communication, interpersonal and decision skills required.  You must have excellent understanding of Pharmaceutical Business and Planning skills.  Must have analytical mind and ability to analyze, summarize data and must be able to communicate technical, scientific, and regulatory information, both written and verbally  Ability to multitask, prioritize and easily adapt to changing situations.  Strong detail – oriented and must be highly organized, disciplined & motivated.  Should be ready and willing to learn new things and implement them at workplace commit towards work & added tasks  Excellent in teamwork, collaboration and demonstrated ability in working independently and as part of a team
 Qualifications: 
   - Education 4 years Bachelor Degree in Pharmacy / any equivalent field.
   - Experience: At least 7 - 9 years’ experience in similar organization in pharma / Health care / Medical Industry.
   - Training:
Key Competencies: Fluent in English, Arabic (communicating, writing and speaking). Proficient in MS Office (MS Excel and MS Word, etc.). Proven experience in reporting and authoring complex scientific documents, producing high quality clinical/regulatory/scientific / medical documents. 
Technical Competencies:  
 

 
 

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