Job Ref. ID:
RA Specialist 1
UNITED ARAB EMIRATES
UAE (RAK head office)
Regulatory Affairs -RA Specialist 1
Full Time Employment (Limited Contract)
Job Summary/ Main Purpose
Specialist 1 - the role holder is responsible to ensure high quality data and standards are used in support of all regulatory applications, providing support to project teams as required. In this role your duties include interfacing with regulatory agencies proactively to respond rapidly and drive license approvals as well as with multiple cross functional stakeholders and project teams in order to proactively plan, coordinate and procure specialty documentation and samples required to support regulatory submissions. Also, responsible for providing input, project related metrics, monthly highlights, troubleshooting documents and sample fulfillment issues and contributing to process and system enhancements.
Key responsibilities & Accountability:
Key Responsibilities & Key Result Areas
• 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.
• Evaluate and identification of documentation gaps during the dossier compilation and communicating with the respective department to fulfil requirements.
• Follow up with the concern departments for getting the relevant documents, which are required for our submission.
• 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 minor changes 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.
• Prepare the required certificates & arrange for the legalization as per the requirements of the different countries, to be included in our registration files.
• Manage review of internal document system for compliance to regulatory commitments and regulations.
• Assure responsibility for a functional area or have a unique contribution to the team and department.
• Relate / contribute to the development of internal policies, processes and procedures supporting the progression and maintenance of the pharmaceutical portfolio at large.
• Lead document management and information management teams, within regulatory department.
• Manage all aspects of the maintenance of allocated marketing authorisations and new submissions and ensure that regulatory based labelling accurate and current.
• Update product specific APQR sheet which comprises of complete approved information related to product at the time of the approval in the related market.
• Collect & evaluate the administrative and technical documents required for the submission to different Health authorities in different countries.
• Prepare monthly report for achievements versus received plan
• 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
• 4 years Bachelor Degree in Pharmacy / any equivalent field.
Minimum 2-3 years of experience working in similar role in the Pharmaceuticals industry, especially with SFDA.
• 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.
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