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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.
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| 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
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| Qualifications: |
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- Education |
• Master degree will be an advantage
- 4 years Bachelor Degree in Pharmacy / any equivalent field. |
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- Experience: |
• At least 5-6 years’ experience in similar organization in pharma / Health care / Medical Industry. |
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- Training: |
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| 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.
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| Technical Competencies: |
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