Job Title: International Associate Regulatory Affairs Director II
Job ID: R-224240
Date Posted: 04/11/2025
Global Career Level: E
Introduction to Role:
Within International Regulatory Affairs (inRA) at AstraZeneca, we apply innovative regulatory approaches to expedite access to life-changing medicines across international markets. Our mission is to accelerate regulatory approvals efficiently so that no patient waits. A permanent opportunity is now open for an International Associate Regulatory Affairs Director II (iARAD II) to join our team, focusing on Established Biopharma Brands that drive growth within the International Region. This hybrid role combines responsibilities of an International Regional Lead and an International Regulatory Affairs Management (iRAM) Lead.
Accountabilities:
Lead the International Regulatory Team (IRT) providing strategic and operational input into growth and life cycle management (LCM) of assigned products.
Develop and deliver international regulatory strategies, aligned with global strategies and commercial needs.
Plan, prepare, and deliver complex regulatory maintenance submissions, including authoring where relevant.
Partner with iCMC to optimize regulatory strategies for current and upcoming variations.
Drive submission delivery strategies and enable efficient Marketing Authorization Application (MAA), Clinical Line Extension (CLE), and LCM submissions.
Coordinate preparation and review of Health Authority Questions (HAQs) responses.
Analyze regulatory procedures and frameworks for applications and maintenance processes.
Maintain and manage submission delivery plans, resource planning, and project tracking.
Represent inRA at Global team meetings and communicate risks and mitigation strategies.
Support compliance activities including content plan generation, submission tracking, and document management.
Promote best practices within the Regulatory Affairs Management (RAM) community and foster effective delivery of submissions.
Partner with Regional Regulatory Contacts for knowledge-sharing initiatives.
Provide coaching and mentoring across iRAM teams to ensure regulatory consistency and right-first-time submissions.
Actively participate in regulatory intelligence initiatives such as the Regulatory Requirements Repository (R3) project.
Seek and implement continuous improvement opportunities.
Essential Skills/Experience:
University Degree in Science or related discipline.
Minimum of 12 years of regulatory experience within the biopharmaceutical industry, especially covering International markets for established products.
Deep understanding of drug development processes and International market regulatory frameworks.
Strong strategic regulatory planning and project management skills.
Proven leadership skills in managing complex deliverables across multiple regions.
Advanced critical thinking, innovation, and influencing capabilities.
High proficiency in both written and verbal communications.
Desirable Skills/Experience:
Excellent English communication skills.
Strong cultural awareness and scientific understanding to facilitate regulatory discussions.
Proficiency in project management and document management tools (e.g., MS Project).
Ability to work independently and collaboratively.
Strong stakeholder management and problem-solving abilities.
Commitment to continuous improvement and knowledge-sharing initiatives.
Additional Information:
At AstraZeneca, we believe that diverse teams bring bold thinking. Our in-person work model promotes collaboration, operating at least three days a week from the office while maintaining individual flexibility. Join our team and be part of a world that inspires innovation, collaboration, and continuous improvement.
We are committed to equality, diversity, and inclusion, welcoming applications from all qualified candidates regardless of background. AstraZeneca complies with all applicable employment laws and regulations.
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