Pharmacist Assistant

Assistant Pharmacist to the Technical Director

1. Job description and role

TheAssistant Pharmacistsupports thePharmacist Technical Directorin 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 coordinatesregulatory submissions regulatory documentation review and batch release notification andHealth Authority (HA) interactions; and ensures timely reporting.

During the Technical Directors absence the Assistant Pharmacist acts as the designatedBack-Up with the same powers and responsibilities for the duration of the replacement.

The position is based at theAlgiers Head Office operates withinAlgeria reports to theAAPI General manager

Key interfaces includeRegulatory Affairs Head of Quality EHS/EQ & ESM Project Leads the General Manager localCMOs and authorities such asANPPand theMinistry 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

• Education: University degree in Pharmacy.
• Experience: 23 years in the pharmaceutical industry within a manufacturing environment ideally covering quality and/or regulatory functions; desirable minimum of 1 year of dedicated regulatory experience.
• Skills and competencies: Working knowledge of Microsoft Office; good knowledge of the pharmaceutical industry requirement; organized and accurate with strong stakeholder management / proficiency in English
• Mobility: autonomous for frequent travel to authorities and potentially to the CMO sites.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.