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Pharmacist Assistant – Regulatory Affairs (Algiers)
Hikma Pharmaceuticals · Algiers
Description du poste
About the role
Hikma Pharmaceuticals is seeking a motivated Pharmacist Assistant to support its regulatory affairs function in Algiers. You will work within a collaborative environment, ensuring that pharmaceutical products meet all regulatory requirements throughout their lifecycle.
Key responsibilities
- Prepare, compile, and submit regulatory dossiers to health authorities in compliance with applicable requirements and timelines.
- Coordinate regulatory activities across the product lifecycle, including dossier preparation, submission, response management, and variation filings.
- Collect and verify required documentation from cross‑functional departments to ensure regulatory compliance.
- Prepare and submit monthly and quarterly warehouse reports, focusing on expired and psychotropic products.
- Manage product destruction (incineration) files and obtain approval from relevant authorities.
- Conduct periodic internal warehouse audits and produce audit reports.
- Ensure timely acquisition of import permits for imported products.
- Participate in regulatory intelligence activities and contribute to continuous improvement of technical and regulatory processes.
Required profile
- Doctor of Pharmacy (Pharm.D.) degree – mandatory.
- Minimum of one (1) year of experience in Regulatory Affairs.
- High level of integrity, confidentiality, and strict adherence to procedures.
- Strong organizational skills, attention to detail, and ability to meet deadlines.
- Excellent written communication skills for interaction with health authorities.
- Ability to work cross‑functionally with various departments.
Required skills
- Strong knowledge of Regulatory Affairs within the pharmaceutical industry.
- Proficiency in Microsoft Excel.
- Proficiency in Microsoft Word.
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Hikma Pharmaceuticals
Algiers
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