Pharmacist Assistant Astrazeneca Pharma India Ltd.

Assistant Pharmacist to the Technical Director

1. Job description and role

The Assistant Pharmacist supports the Pharmacist Technical Director in executing all technical and regulatory activities for locally manufactured AstraZeneca products in Algeria, ensuring alignment with Algerian Health Authority laws and AstraZeneca global codes, standards, and procedures.

The role coordinates regulatory submissions, regulatory documentation review and batch release notification , and Health Authority (HA) interactions; and ensures timely reporting.

During the Technical Director s absence, the Assistant Pharmacist acts as the designated Back-Up, with the same powers and responsibilities for the duration of the replacement.

The position is based at the Algiers Head Office, operates within Algeria, reports to the AAPI General manager,

Key interfaces include Regulatory Affairs, Head of Quality, EHS/EQ & ESM, Project Leads, the General Manager, local CMOs, and authorities such as ANPP and the Ministry of the Pharmaceutical Industry.

2. Accountability

• Regulatory declarations and reporting: Declare batch releases to the National Agency of Pharmaceutical Products; submit weekly, monthly, and annual stock level reports to the Ministry of the Pharmaceutical Industry; declare expired products, incinerated products, and production schedules to the Ministry; submit the annual inventory of pharmaceutical products as per ministerial procedures.
• Regulatory documentation review: Review and verify completeness, accuracy, and consistency of regulatory documents and dossiers (e.g., registration/approval files, variations, import programs, batch release packages, HA responses), ensuring alignment with approved data, GMP, and internal quality systems prior to submission or release.
• Product quality ;Pre-notify the Ministry of any modification affecting quality, safety, or efficacy relative to the approved registration/approval dossier.
• Import program: Prepare and submit the provisional import program for API, raw materials and packaging items to the Ministry responsible for the pharmaceutical industry.
• Health Authority interactions and follow up : HA interactions and respond to HA queries consistently, within required timelines, and in accordance with internal guidelines.
• Acting Technical Director (Back-Up): Assume the responsibilities of the Pharmacist Technical Director during periods of absence.
• Stakeholder collaboration: Work closely with internal stakeholders (Regulatory Affairs, Quality, EHS/EQ & ESM, Project Leads, General Manager) and external partners (ANPP, Ministry of the Pharmaceutical Industry, local CMOs) to ensure compliant, timely delivery of regulatory and operational obligations.

3. Required qualification