Regulatory Affairs Director at AstraZeneca

AstraZeneca

Join AstraZeneca as an Associate Regulatory Affairs Director, leading the regulatory submissions process and ensuring compliance while working flexibly in downtown Toronto. Leverage your project management skills and regulatory expertise to drive successful drug development outcomes. As a key role at AstraZeneca, you will work within a collaborative team to manage complex regulatory applications. Your extensive regulatory experience will guide cross-functional teams through submission strategies while identifying and mitigating risks. This role promotes innovation in a flexible environment, enhancing your ability to impact global health solutions. Key Responsibilities:

Lead regulatory submission strategies and complex applications
Review and provide input on essential documents
Develop and maintain submission content and delivery plans
Identify regulatory risks and propose mitigations
Coach and mentor Regulatory Affairs team members

Requirements:

Relevant University Degree in Science or related discipline
Over 5 years of regulatory experience in biopharmaceuticals
Strong project management and leadership skills
Knowledge of drug development processes
Familiarity with AI digital tools and Veeva Vault

Bring your expertise in regulatory affairs and project management to AstraZeneca, driving impactful drug development initiatives. #J-18808-Ljbffr

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Vacancy posted 2 days ago

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