Isaac Haynes

Regulatory Affairs Manager - Oncology @AstraZeneca

Mississauga, ON, CA

As a Regulatory Affairs Manager, I lead and coordinate global and regional regulatory deliverables, driving the successful submission of clinical trial/IND applications, marketing applications (MAA/NDA), lifecycle amendments, health authority interactions, responses to health authority questions, scientific advice, paediatric study plans and other critical regulatory documentation across key global markets, including the United States (US), European Union (under EU-CTR), and rest of world (RoW) regions. With a strong background in managing regulatory applications and submissions, I collaborate closely with CROs, cross-functional teams such as clinical, non-clinical, patient safety, and CMC, ensuring compliance with regulatory requirements and timely approvals. I specialise in the development and execution of submission plans, creating and maintaining dossier content plans, and authoring key regulatory documents including cover letters, letters of authorisation, and FDA forms. My role extends to managing operational and compliance activities for regulatory deliverables, including submission tracking, document management, and trial master file maintenance. I also focus on identifying risks and opportunities within the submission process, providing strategic guidance, and working across regions to align regulatory efforts with business objectives. With expertise in leveraging regulatory tools and platforms such as Veeva Suite, Planisware, Microsoft Project, IRIS, and CTIS, I ensure efficient management of regulatory activities. I am also dedicated to continuous process improvement, mentoring colleagues, and fostering knowledge-sharing to enhance performance and efficiency within the regulatory department.

Kingston University

Bachelor of Science - BSc (Hons), Pharmacology

Cardiff University / Prifysgol Caerdydd

Master of Science - MSc, Clinical Research