:
* Preparation of license renewals and variation files according to current Ministry of Health requirements on all products for assigned countries
* Do the submission compilation, publishing and approval information processes and tools.
* Seeks opportunities and develops "rapport" with immediate colleagues to formulate relationships within the organization.
* Supports local distributor 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.
Key Areas of Responsibility:
* Supports all activities related to the registration and maintenance of products in compliance with all local and global codes, standards and procedures as well as HA laws and regulations as follows:
* Adequate preparation and compilation of submission dossiers.
* Ensure timely submission of registration dossiers according to the MC plans of submission.
* Obtaining regulatory approvals and ensuring maintenance/variation procedures are effectively in place.
* Follows up the variations approval process implementing the regulatory activities established by the law and by AZ
* Ensuring administrative validation, chasing up the dossier throughout the assessment and anticipating the possible questions from the Competent Authorities including Ad Hoc queries in order to optimize the timing, the quality of the answers and the Marketing Authorization (MA) approval and Summary of Product Characteristics (SPC) wording.
* Answer Queries from health authorities in a consistent manner and within the time limits and in any case according to internal guidelines
* Communicating all variations and changes to the regulatory authorities in accordance with the respective legal requirements
* Liaise closely with QA and RPM on all aspects affecting variations and change control to ensure timely and appropriate answers to the queries raised by the HA.
* Regulatory Affairs Specialist is responsible for updating the MC with all HA changes that may affect AZ products in any way.
* Ensure collection of all product related HA correspondences from the HA
* Ensure effective documentation and archiving of all submission and approval documents
* Maintenance of all regulatory databases (CARA, Register, GAZELLE, IMRI & ERV).
* 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 with the team members
Minimum Criteria and Competencies
* Pharmacy Degree.
* Ability to interact and manage a range of stakeholders both internally and externally.
* Meticulous and oriented for details.
* Learning agility.
* At least 2-3 years in AstraZeneca in a sales or marketing function.
* Knowledge of AstraZeneca local and HQ SOPs and Codes
* Excellent written and verbal communication skills
* Precision and accuracy.
* Influencing and negotiating skills
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