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Regulatory Affairs Specialist
2 weeks ago
A career opportunity exists for a skilled Regulatory Affairs Executive to join our team.
The ideal candidate will possess strong knowledge of regulatory affairs, product classification, and importation regulations. They will be responsible for ensuring that all products comply with the regulations of the National Health Regulatory Authority (NHRA). Additionally, they will be expected to maintain up-to-date knowledge of the latest changes in regulatory legislation and guidelines.
The successful candidate will have excellent interpersonal skills and good English language proficiency. They will also have good computer skills in Microsoft Office, particularly Excel and ERP/Oracle systems. Experience in regulatory affairs within Bahrain is preferred, but fresh graduates are also encouraged to apply.
About this Role- Ensure that all required documents and actions for Product Classification/Mfg Site Registration and Product Registration are available.
- Prepare and submit documents for NHRA registration.
- Collect necessary documents from suppliers for submission to Health Authorities.
This role requires attention to detail, organizational skills, and the ability to work effectively in a fast-paced environment.
Responsibilities include:
- Monitoring Cold Products from receiving to delivery to customers, along with Data Logger results within temperature limits.
- Examining packing of goods from cold storage and monitoring Data Logger Report to ensure consistency.
- Checking quality of vehicles, warehouse cleanliness, temperature control mechanism, storage conditions, and validity of goods on shelves regularly.
- Ensuring calibration of Zahrawi Cold Vans/Delivery Vehicles, Data Loggers, and updating Warehouse temperature mapping.
The ideal candidate should have experience in Pharmacovigilance related work and be able to manage the Pharmacovigilance process by preparing SOPs, product safety reviews, and literature reviews when needed.
They should also be able to prepare and review Pharmacovigilance plans for Suppliers and communicate these plans to stakeholders.
The job involves administrative tasks, such as developing professional relationships with regulatory authorities, proactively monitoring legislative changes, and representing the company at relevant governmental bodies.
Additionally, the candidate will assist the Warehouse Coordinators with documentation and coordinate with the Procurement team regarding supplier queries related to NHRA importation.
Requirements- Bachelors Degree in Pharmacy.
- Candidates must be based in Bahrain.
- Bahraini national is preferred.
- Candidates must have a valid Pharmacist license.
- RAO license is a plus.
- Experience: Fresh graduates or 1+ years of relevant experience in regulatory affairs within Bahrain is preferred.
This role offers opportunities for professional growth and development in a dynamic and challenging environment.
The successful candidate will be part of a dedicated team working together to achieve excellence in regulatory affairs.
