Job Description:

• Supports all activities related to Divestment projects in Iraq & Jordan 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.
  • Obtaining approvals and ensuring variation procedures are effectively in place, in a timely manner
  • Follow and support the local distributor
• Follows up the variations approval process implementing the regulatory activities established as per MOH guidelines and by AZ
• Answer Queries from health authorities (HA) in a consistent manner and within the time limits and in any case according to internal guidelines
• 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 Tools management; in a timely manner, including translation of HA communication/approvals, in case needed. This is to ensure effective documentation and archiving of all submission and approval documents
• Communicating official regulations and guidelines issued by the HA to the global teams through AZ proper channels. This includes IMRI update and the Regulatory Intelligent forms.

Personal responsibility to collaborate with the team members and different Stakeholders in respect to AZ-Core Values.

Job Requirements:

Essential:

• University degree in science or related discipline
• Fluent English
• 1-2 year of Regulatory experience
• Working knowledge of MS office
• Aware of and complying with the Code of Conduct of the pharmaceutical industry 
• Organized, high political intelligence and accurate

Desirable:

• CTD & eCTD knowledge

Date Posted

08-Jan-2020

Closing Date

18-Jan-2020

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.