Job Title: International Associate Regulatory Affairs Director II
Job ID: R-224237
Date Posted: 04/11/2025
Global Career Level: E
Introduction to Role:
Within International Regulatory Affairs (inRA) at AstraZeneca, we drive innovative regulatory approaches to ensure life-changing medicines reach international markets efficiently. We work across the AZ pipeline to accelerate regulatory approvals and deliver medicines so that no patient waits.
We are seeking a permanent International Associate Regulatory Affairs Director II (iARAD II) to join our International Regulatory Affairs team. This hybrid role will act as an International Regional Lead and International Regulatory Affairs Management (iRAM) Lead for Established Biopharma Brands, supporting the foundation for growth across international regions.
Accountabilities:
The iARAD II will demonstrate both strategic competence and tactical regulatory expertise by:
Leading the International Regulatory Team (IRT) and providing strategic and operational regulatory input for growth and lifecycle management (LCM) of assigned products.
Planning, preparing (including authoring where necessary), and delivering complex regulatory maintenance submissions from an International market perspective.
Partnering with iCMC to monitor variations and develop optimal regulatory strategies aligned with commercial and medical needs.
Developing and delivering International regulatory strategies while driving the planning, coordination, and tracking of regulatory submissions.
Advising on tactical decision-making to optimize submission delivery strategies for assigned products/markets.
Facilitating rapid filings and responding to Health Authority Questions (HAQs) by coordinating, reviewing, and authoring contributions.
Analyzing regulatory procedures and contributing to the strategy for product development, marketing authorization, and line extensions.
Maintaining submission plans, tracking regulatory activities, and proactively providing status updates to stakeholders.
Representing inRA at Global meetings for international market strategy discussions and issue resolution.
Identifying regulatory risks and communicating mitigation strategies to stakeholders.
Supporting operational compliance activities, document management, and Health Authority interactions as required.
Promoting best practices within the RAM community to ensure high-quality and consistent International market submissions.
Coaching and mentoring colleagues, promoting continuous improvement initiatives, and sharing regulatory insights.
Participating in Regulatory Intelligence initiatives and maintaining strong regulatory framework knowledge across small and large molecules.
Essential Skills/Experience:
Relevant university degree in Science or a related discipline.
12+ years of extensive regulatory experience within the biopharmaceutical industry, particularly with International markets for established products, CLEs, and license maintenance.
Strong understanding of drug development and International regulatory frameworks.
Expertise in new MAA roll-out and product maintenance processes.
Strategic regulatory skills with robust project and stakeholder management capabilities.
Proven experience in leading high-performing, multidisciplinary teams.
Track record in managing complex regulatory deliverables for International market MAAs, CLEs, and LCM activities.
Demonstrated competency in critical thinking, strategic influencing, innovation, leadership, and advanced communication skills.
Desirable Skills/Experience:
Excellent English written and verbal communication skills.
High level of cultural awareness.
Strong scientific background to support regulatory discussions.
Proficiency with project management and document management tools.
Ability to work independently and collaboratively within a team.
Strong influencing and stakeholder management capabilities.
Analytical mindset for problem-solving and recommending actionable solutions.
Commitment to continuous improvement and knowledge sharing.
Working Environment:
At AstraZeneca, we believe in working together in-person for three days per week to drive bold thinking and foster collaboration, while offering flexibility to respect individual needs. We are dedicated to continuously improving our processes and advancing our innovative pipeline, with a focus on delivering results efficiently and effectively for patients worldwide.
Diversity and Inclusion:
AstraZeneca is committed to building a diverse and inclusive workforce. We welcome applications from all qualified individuals regardless of background and ensure compliance with all applicable employment laws and regulations.
Ready to make a difference? Apply now!
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