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Job Ref. ID:  50530 
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 • Master degree will be an advantage - 4 years Bachelor Degree in Pharmacy / any equivalent field.
   - Experience: • At least 5-6 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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