Regulatory Affairs Group Director, International Regulatory Affairs

AstraZeneca · Petaling Jaya

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Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AZ pipeline and business to accelerate Regulatory approvals for new medicines in International markets as efficiently and effectively as possible so that no patient waits.

An opportunity has now arisen for a Regulatory Affairs Group Director to join our International Regulatory Affairs team. The role is to provide leadership to a team of staff leading regulatory submissions to International Regulatory Agencies around the world. You will use your Regulatory expertise to support your team members and their professional development in navigating through complex Regulatory frameworks with the aim of securing first Regulatory MAA approvals, clinical line extensions and life cycle maintenance activities in International markets. The AstraZeneca pipeline is fast moving with International acceleration a priority therefore you will need to possess an excellent understanding of Int’l Regulatory Affairs to lead and motivate staff and ensure the priorities for International markets is delivered efficiently and effectively.

What you will do:

• Provide leadership, coaching and line management for a number of direct reports across different geographies. Ensure the principles of both individual and team performance development are used to develop and develop staff to their full potential
• Development of International market organisational capability, active promotion of a knowledge sharing culture and continuous improvement mentality within International Regulatory Affairs as a Subject Matter Expert
• Attract and recruit talent. Be an ambassador for the Int’l Regulatory Affairs, able to engage stakeholders and clearly articulate the RAM roles and responsibilities.
• As a senior member of Int’l Regulatory Affairs RAM community, proactively contribute to the strategy, direction and efficient operation of the group. Develop and deliver departmental performance targets for the Int’l Regulatory organisation.
• Responsibility for development of solutions to resourcing TA projects with International market iRAMs working collaboratively with the Int’l Senior Regulatory Affairs Director to ensure cost effective and flexible resource management which is aligned with Int’l market priorities
• Ensure own work and work of direct reports adheres to and remains in compliance with AZ standards, processes, AZ group policies and corporate responsibilities.
• Has an in-depth regulatory knowledge and understanding of RAM roles, Submission Excellence and Regulatory Operating Model and can support individuals as needed with typical activities at a global and/or regional level to ensure delivery of project objectives on time and to appropriate quality. 
• Lead continuous improvement initiatives within International RA as well as representing Int’l RA on cross-functional initiatives
• Drive the development of pioneering RAM capabilities as well as system and process improvement ideas driving efficiency gains across Int’l Regulatory Affairs
• Influence the image of the business externally and also may represent AZ externally as part of an industry association and/or International Advocacy programme

Essential Requirements:

• University Degree in Science or a related field
• Extensive regulatory experience within the biopharmaceutical industry and/or experience at a health authority.
• Previous line management and project resourcing experience
• Knowledge of regulatory procedures and legislation for drug development, throughout the product lifecycle with particular emphasis on new Marketing Authorisation Applications (MAAs) & Clinical Line Extensions (CLEs) and Lifecycle Maintenance (LCM) for International markets.
• Proven successful leadership of multi-disciplinary, cross-functional teams and extensive project management experience
• Thorough knowledge of International Regulatory Affairs as a Subject Matter Expert
• Proven ability to drive and implement change and improvement projects
• Strong influencing, stakeholder management and negotiating skills.
• Excellent written and verbal communication skills

Date Posted

Closing Date

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.

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