Regulatory Affairs Specialist

:

• Organizes submission plans on all products for assigned countries.
• Implement the agreed regulatory strategy regarding new products and maintain products licences in the allocated countries.
• Be part of the team planning the strategy for regulatory activities for the allocated 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 organisation.
• 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:

• Support in setting the regulatory strategic plan.

• Supports all activities related to Life Cycle Maintenance (License/Sites Renewals & Products Variations) for all AZ products across the assigned markets in compliance with all local and global codes, standards, and procedures as well as HA laws and regulations.

• Follow proper communication process for Consultation, dispatch, submission, and approval with all relevant stakeholders.

• Finalize the received consultations & settings Submission plans across the markets by assessing the submission & approval timelines Vs the global planned implementation dates.
• 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 ensure approvals granted within the standard Leadtime without delays.
• Submission of all types of variations and changes to the regulatory authorities in accordance with the respective legal requirements and as per global & MC plans
• Prioritizing the important submissions (e.g., Safety updates, new indications. Etc.) to ensure alignment with the global planned implementation of the new leaflets.
• Answer queries from health authorities in a consistent manner and within the time limits and in any case according to internal guidelines, by liaising 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 HAs.
• Follows up the variation's approval process, implementing the regulatory activities established by the law and by AZ.
• Updating the internal & global systems with the submissions and approvals dates on regular basis.
• Submission of LCM dossiers, as per the timelines set for each market.
• Answer queries from health authorities in a consistent manner and within the time limits and in any case according to internal guidelines
• Follows up with HAs/local agents to attain the approvals within the standard lead time.
• Updating the internal & global systems with the submissions and approvals dates on regular basis
• Regular validation of the global forecast Vs the local MC plans/ timelines, to ensure alignment of global & local plans.
• Following the GRP process to ensure compliance & alignment between the global & local database, Regulatory Affairs Sr. Specialist is responsible for updating the MC with all HA changes that may affect AZ products in any way, and ensure effective documentation and archiving of all submission and approval documents via updating the local and global AZ systems/ trackers:
• Interacts with the local IS/IT function and the Regulatory Heads in the realization, implementation, and maintenance of the regulatory tools.
• Protect and enhance long-term Company performance and reputation by doing the right thing.
• Has personal responsibility for creating a culture of courageous leadership, creativity, and collaboration with the team members.

Minimum Criteria and Competencies

• Pharmacy Degree.
• 0 - 2 years of experience
• Ability to interact and manage a range of stakeholders both internally and externally.
• Meticulous and oriented for details.
• Learning agility.
• Excellent written and verbal communication skills.
• Precision and accuracy.
• Influencing and negotiating skills.
• Excellent English Language