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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 (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: |
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- Education |
4 years Bachelor Degree in Pharmacy / any equivalent field. |
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- Experience: |
At least 7 - 9 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. |
| Technical Competencies: |
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