Associate Director, Regulatory Affairs International Regulatory Affairs Global Regulatory Affairs

This is what you will do :

The Associate Regulatory Affairs Director, International Regulatory Affairs, plays a critical role in the development and implementation of regulatory strategies for technologically complex products across international regions, particularly focusing on rare diseases and unmet needs. This role involves serving as the International Regulatory Lead (IRL) for assigned projects, aiming for successful registration and lifecycle management. The Associate Director also participates in transversal regulatory and cross-functional initiatives, aligning projects with international standards and supporting geographic expansion. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.

You will be responsible for :

• Regulatory Strategy Development: Serve as the International Regulatory Lead (IRL), responsible for the strategy and facilitating regulatory submissions for assigned products in compliance with regional requirements ensuring successful registration and lifecycle management.
• Collaboration & Communication: Build effective working relationships with cross-functional teams, Alexion affiliates, and AstraZeneca shared marketing companies to deliver on business objectives.
• Stakeholder Interaction: Engage with international and global regulatory and cross-functional project colleagues to facilitate compliant and successful regulatory submissions in the international regions aligned with the global strategy.
• Mentorship & Guidance: Mentor and guide Regulatory Affairs team members, providing support to enhance their skills and capabilities.
• Process Enhancement: Participate in initiatives aimed at improving regulatory workflows and contribute to innovative approaches within the regulatory function.
• Risk Assessment: Identify and manage regulatory risks, leveraging cross-functional expertise to develop solutions and ensure project success.
• Regulatory Innovation: Navigate and apply latest internal and external regulatory requirements and trends for assigned project.
• Exemplary Leadership: Maintain exemplary behavior, ethics and transparency within the Enterprise, with Health Authorities and other external stakeholders.

We would prefer for you to have :

• 7+ years of Regulatory experience in the pharmaceutical industry, with significant track record on International and/or Global Strategies.
• Strong knowledge of drug development and regulatory intelligence, coupled by excellent scientific and business judgment.
• Experience providing strategic regulatory advice for the global development of products in International through several stages of development including pre-approval and marketed assets.
• Ability to manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion.
• Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization, especially Senior Management.
• Ability to understand and leverage cross-functional expertise to build compelling and successful regulatory strategies
• Strong interpersonal, and written/verbal communication skills.
• Proven track record practicing sound judgment as it relates to risk assessment
• Keen understanding of new and emerging regulations and guidance's, and comprehensive understanding of GxPs and regulatory information sources.

Education :

• Bachelor’s Degree, life science highly desirable
• Postgraduate degrees relevant to the role (e.g. MSc, PhD) a plus
• Additional certification and/or training relevant to the role over the past

At AstraZeneca, we are driven by our passion to serve patients. Our work is led by their lived experiences, driving what we do and how we do it. We know our patients by name, meet their families, and understand their journeys. Our entrepreneurial spirit combined with our pioneering approach makes us unique in R&D and healthcare. Join us to grow in a rapidly expanding portfolio, enjoy an energizing culture, and make a real impact on the lives of underserved patients worldwide.

If this sounds like a team you want to be a part of, we’d love to talk.

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.