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Job Ref. ID:  50583 
Job Title: RA Specialist 2
Division: REGULATORY AFFAIRS
Country: UNITED ARAB EMIRATES
Work Location: UAE (RAK head office)
Job Type: Regulatory Affairs -RA Specialist 2
Employment Type: Full Time Employment (Limited Contract)
Job Description:
Purpose: Specialist 2 - the role holder is responsible to ensure to provide strategies for the regulatory projects, resources, costs, time and clients. Accountable for the preparation of requirements of products to be registered and submitted to the Ministry of Health. Responsible for all regulatory activities including dossier assessment, Gap analysis of regulatory Technical work with Health Authorities or/and Food and Drug Administration. Calumniation with agent & distributers in countries to follow and update registration (renewal and variation status). As well as prepare variation planning as the approved CCF and distributed along with the team.
Key responsibilities & Accountability: Key Responsibilities & Key Result Areas • Preparation & submission for renewal files before expiry date in countries as per their requirements to avoid losing registration license. • Reviewing all the variation files regarding the formula (active & inactive ingredients), additional pack sizes, change in the packaging materials (leaflets, inner & outer packs), the dosage form, increase of shelf life & storage condition for different health authorities (for the above mentioned market ) as per their requirements & as per management planning & request . • Gap analysis preparation then variation files Preparation for different health authorities as per their current guidelines & as per management request. • Arrange the sample with approved packaging materials as per country requirements. • Responsible to provide response for all the queries which received from countries within timeline. • Monitor the performance of the Compliance Program and relates activities on a continuing basis, taking appropriate steps to improve its effectiveness. • Ensure proper reporting of violations or potential violations to duly authorized enforcement agencies as appropriate and/or required. • Advise on regulatory strategy and executing specific submission through regulatory agents. • Manage all parts of a regulatory project including overall strategy, resource, costs, time and clients. Choose the method and processes of work to achieve overall objectives. • Investigate opportunities for regulatory innovation / promote the use of novel approaches within team to resolve issues and problems. • Prepare the Registration Dossiers for the Health Authorities in different countries as per their current guidelines and the preparation of the Technical file for Drug Control Laboratory. • Prepare the Renewal / Re-Registration of the products to the different Health Authorities. • Notify the Minor Changes regarding the Formula (Active & Inactive Ingredients), Additional Pack Sizes, and Change in the Packaging Materials (Leaflets, Inner & Outer Packs), the Dosage Form, and Increase of Shelf Life & Storage Condition. • Prepare the required certificates & arrange for the legalization as per the requirements of the different countries, to be included in our Registration Files. • Responsible for the follow up the requested documents from different departments. • Relate / contribute to the development of internal policies, processes and procedures supporting the progression and maintenance of the Pharmaceutical portfolio at large. 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
 Qualifications: 
   - Education • 4 years Bachelor Degree in Pharmacy / any equivalent field.
   - Experience: Minimum 2-4 years of experience working in similar role in the Pharmaceuticals industry, especially with SFDA.
   - Training:
Key Competencies: • Should have handled similar role for a better fitment. • Strong command in English & Arabic (communicating, writing and speaking). • Proficient in MS Office (MS Excel and MS Word, etc.). • Strong Knowledge of a specific regulatory discipline and the principles, concepts and theories governing Regulatory Affairs.  
Technical Competencies:  
 

 
 

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