Regulatory Affairs Manager

Job Purpose:

Resposnible for the management of all the regulatory related activities in certain country such as submissions, MAH approval and  regulatory affairs project management, etc.

Responsible to achieve the agreed internal objectives on MC scorecard.

Key Areas of Responsibility:

• Proactively contributes to the strategy, direction and efficient operation of a regulatory affairs skill group by continuously enhancing the organisation and operating model
• Builds and develops optimum global working relationships and processes with other key stakeholders in AstraZeneca Regulatory Affairs to gain efficiencies
• Leads or participates in cross-functional global business projects, providing expert regulatory advice
• Leads the regional performance management process between the Group Manager, direct reports and relevant Regulatory Affairs Directors, ensuring objectives are agreed and monitored
• Actively and objectively collaborates with Regulatory Affairs Directors and other managers to deliver robust performance for global group
• Liaises with other Group Mangers to ensure that direct reports broaden their experience within all areas of regulatory affairs core activities and develop their global regulatory experience across the European Union, United States, Japan and the rest of the world
• Identifies global budget priorities, taking careful note of portfolio growth and business needs
• Leads or participates in cross-functional global and regional delivery teams for complex submissions, providing expert regulatory advice
• Identifies potential complex regulatory risks to global and regional operational plans, and propose options to mitigate risks
• Leads and provides regulatory expertise on global and regional regulatory submissions and health authority briefings
• Complies with, or is aware of all relevant AstraZeneca policies, and AstraZeneca Regulatory Affairs and cross-functional procedures
• Building and maintaining excellent relationship with health officials
• Corresponding with HQ regarding preparation of the registration dossiers for new products and renewals
• Reviewing , submitting files and following through the entire registration process
• Preparing all the documentation needed from the MOH for  scientific office branches and stores , getting the approvals and following up on regular checks and re-approvals
• Supervising and helping the external party responsible for clearing documents and samples from customs
• Keeping his manager and AZ staff informed about the updates of registration and regulations in MOH

Minimum Criteria and Competencies

• University degree in science or related discipline
• Considerable experience of working in one or more areas in regulatory affairs in the pharmaceutical or related industry
• 3-5 years’ experience in local manufacturing regulatory affairs department
• Experience leading a cross functional project team
• A min. of 5 years’ experience in registration and MOH affairs
• Very good command of English language
• Computer knowledge
• Aware of and complying with the ethics of pharmaceutical industry 

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.