Regulatory Affairs Specialist

Major Accountabilities

• 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 AdHoc queries in orderto 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 set by the agency when indicated 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-EM 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 (REGISTER, ANGEL/GEL, IMRI, eSUF......).
• 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

• Pharmacovigilance: meeting all the regulatory HA requirements of Pharmacovigilance System Master File, Periodic Benefit Risk Evaluation Report (PBRER), Risk Management Plan (RMPs and answering all HA queries/requests in timely manner.
• Education and training of AZ employees/external stakeholders on AE reporting.
• Receipt and timely submission of Individual case safety reports (ICSRs) on JASPER and to local HA per local regulations.
• Ensuring all updates in PV guidelines/timelines are effectively communicated to global PV.
• ·Good Regulatory Practice (GRP): maintenance of good regulatory practice, provide the global team with quarterly reports reflecting our local compliance and practice.