Regulatory Affairs Officer
Mussafah, United Arab Emirates
Job Description
Regulatory affairs officers act as a link between companies and regulatory authorties, ensuring that products are manufactured and distributed in compliance with appropriate legislation. Responsible for all Product Classification/Manufacturing Site Registration and Product Registration and ensuring that all documents required are available and are submitted on time.
- Responsible about any medicine received or dispatched from the stores
- Prepare and apply for the pre-permit and post-permit (shipment release) documents as per the MOH guidelines and verify the items being imported and the documents required.
- Communicate with the existing and new suppliers regarding MOH importation rules and policies.
- Upload on the MOH importation system any new classifications or registration certificates.
- Prepare any documentation needed for internal and external audits.
- File all documents in the corresponding files to ensure all are available and correct.
- Collaborate with manufacturers and external partners to identify potential new medicines and medical devices for development and commercialization.
- Conduct thorough assessments, including market analysis, competitive landscape evaluation, and profitability projections.
- Conduct financial analyses, including cost projections, revenue forecasting, and profit margin assessments for potential products.
- Develop and implement regulatory strategies to support the registra,on and approval of new products or changes to existing products.
- Stay up-to-date with evolving regulatory requirements and ensure compliance with local, national, and international regulations.
- Serve as the primary point of contact for regulatory agencies and represent the company in interactions with health authorities.
- Establish and maintain positive relationships with regulatory agencies to facilitate successful submissions and approvals.
- Studying scientific and legal documents
- Find new opportunities to register potential products
- Communicate with manufacturer and supplier to identity new potential products
- Gathering, evaluating, organizing, managing, and collating information in a variety of formats
- Ensure that Sky Health Drug Store products comply with the regulations of the MOH.
- Keep up to date with the latest changes in regulatory legislation and guidelines.
- Liaise and negotiate with regulatory authorities to ensure a smooth registration process.
- Ensure that all required documents and actions for Product Classification/Manufacturing Site Registration and Product Registration are available.
- Bachelor\'s (Required)
- Regulatory affairs drug registration: 1 year (Required)
- Pharmaceutical Distributor company: 1 year (Required)
- In Charge Pharmacist in Pharma Distributor company: 1 year (Required)
- MOH or DOH or DHA license in Pharmacy (Required)
- Mussafah (Required)
- Mussafah: Relocate before starting work (Required)
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Job Detail
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Job IdJD1629178
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationMussafah, United Arab Emirates
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EducationNot mentioned