Pharmacist Assistant – Regulatory Affairs

About the role

Hikma Pharmaceuticals is seeking a Pharmacist Assistant to support its regulatory affairs function in Algiers. The role involves preparing and managing regulatory dossiers, ensuring compliance across the product lifecycle, and collaborating with cross‑functional teams.

Key responsibilities

• Prepare, compile, and submit regulatory dossiers to health authorities in compliance with applicable requirements and timelines.
• Coordinate regulatory activities throughout 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, particularly for expired and psychotropic products.
• Manage product destruction (incineration) files and obtain approval from relevant authorities.
• Conduct periodic internal warehouse audits and prepare 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 degree (mandatory).
• Minimum of one (1) year of experience in Regulatory Affairs.
• Strong knowledge of regulatory affairs within the pharmaceutical industry.
• Excellent written communication and interaction skills with health authorities.
• Strong organizational skills, attention to detail, and ability to meet deadlines.
• Ability to work cross‑functionally with different departments.
• High level of integrity, confidentiality, and adherence to procedures.

Required skills

• Regulatory Affairs
• Microsoft Excel
• Microsoft Word