Regulatory Affairs Professional for Pharmaceutical Industry
5 days ago
Zahrawi Group is a leading healthcare industry company in the GCC with a presence in UAE, KSA, Qatar, Bahrain, and Oman markets.
The Regulatory Affairs Executive & Warehouse Pharmacist will be responsible for ensuring that all products comply with regulations and guidelines set by the NHRA.
Key Responsibilities- Regulatory Affairs: Ensure compliance with NHRA regulations, keep up-to-date with latest changes in legislation and guidelines, and liaise with regulatory authorities to ensure smooth registration processes.
- Product Classification & Registration: Prepare documents for product classification, manufacturing site registration, and product registration, and ensure all required documents and actions are available.
- Pharmacovigilance: Monitor adverse drug reactions, report to relevant health authorities, and maintain records of ICSR reports.
- Quality Assurance: Monitor cold products from receiving to delivery, examine packing and data logger results, and check warehouse cleanliness and temperature control.
- Warehouse Quality Check: Ensure warehouse and service room cleanliness, temperature control, and hygiene standards are maintained.
- Product Quality Check: Secure samples from WH Assistants, provide progress reports, and compile quality inspection forms.
- Audit: Prepare documentation for internal and external audits, file documents, and evaluate suggestions.
This role requires strong interpersonal skills, good English language skills, and knowledge of regulatory affairs, product classification, and importation regulations as per NHRA.
Candidates must have a Bachelor's degree in Pharmacy, be based in Bahrain, and possess a valid pharmacist license. RAO license is a plus. Fresh graduates or 1+ years of relevant experience in regulatory affairs within Bahrain are preferred.
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