- Entreprise : Astrazeneca
- Fonction : Santé, Médical, Pharmacie
- Secteur : Industries
- Lieu : Alger
Job Description / Capsule
Assists with global/regional tactical submission plans on allocated projects/products that implement the agreed regulatory strategy to develop and maintain products. Fluent with submission compilation, publishing and approval information processes and tools. Seeks opportunities and develops « rapport » with immediate colleagues to formulate relationships within the organisation. Supports the Regulatory team in all the activities related to the registration and maintenance of products in compliance with all local and global codes, standards and procedures. Supports the Regulatory Director/regulatory team in all activities related to budget monitoring and control.
Typical Accountabilities
– Supports all activities related to the registration and maintenance of products in compliance with all local and global codes, standards and procedures
– Assists with regulatory file compilation and submissions, regulatory approval and maintenance procedures including maintenance of regulatory databases.
– Follows up the variations approval process implementing the regulatory activities established by the law and by AZ
– Maintains regulatory/technical archive of product and tracking of submission/achievements being able to satisfy the requirements of any audit or inspection
– Interacts with the local IS/IT function and the Regulatory Heads in the realization, implementation and maintenance of the regulatory tools
– Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration
Education, Qualifications, Skills and Experience
Essential
– Experience in the regulatory department
– Knowledge of the local and HQ SOP and Codes
– Knowledge of informatics system and programs
Desirable
– Precision and accuracy
– Flexibility
Key Relationships to reach solutions
Internal (to AZ or team)
– RA Director
– Regulatory Department
– Finance Department
– Local IT/IS function
External (to AZ)
– Marketing Companies
– International Regulatory Affairs
Skills
– Registration
– Reimbursement
– Labelling
– Quality Assurance ( not mandatory)
Work experience :
– Preparation of registration files.
– Preparation, review and approval of French\Arabic labeling.
– Approval of promotional material.
– Preparation of reimbursement files (administrative preparation only)
