Job Description

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation \xe2\x80\x93 ultimately providing employees with the opportunity to work across teams, functions and even the globe.Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we\xe2\x80\x99re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.Introduction to role:Join us at AstraZeneca\'s Oncology Business Unit as a Regulatory Affairs Clinical Trials Lead. This role is pivotal in preparing and implementing regional regulatory tactical submission plans on allocated projects/products. You will be responsible for generating and project leading the delivery of submissions, ensuring compliance with Regulatory standards. This is your chance to make an impact at every point in the patient journey, changing the way cancer is treated!Accountabilities:As a Regulatory Affairs Clinical Trials Lead, you will be responsible for:

• Providing oversight and accountability for regulatory strategies and tactics to deliver the clinical trial application (CTA) portfolio in Canada, including initial CTAs, CTA amendments and CTA notifications, aligned to Health Canada and company requirements, and in coordination with global priorities, teams, and tactics.
• Proactively identifying and advising global teams of risks related to CTA approvability and execution, such as investigational drug labeling requirements.
• Maintaining subject matter expertise, and demonstrating in depth knowledge and application of Regulatory compliance and submissions.
• Developing and building positive relationships with internal customers and Regulatory authorities, improving Regulatory outcomes.
• Leading, managing and supporting the submission review process (eg, responding to clarifaxes).
• Providing regulatory input and direction to the Canadian Cross Functional Team and Global Clinical and Regulatory teams to develop and refine clinical trial strategies, deliver optimal Health Canada approvals (time and quality), maintain compliance, and positively impact the product portfolio and clinical R&D activity in Canada.
• Actively supporting the team to improve efficiency, performance and productivity.
• Overseeing, developing and implementing regulatory strategic plans including Regulatory Strategy Documents for novel trials with registration intent (as required).
• Overseeing, preparing for and leading pre-CTA meetings with Health Canada (as required). Working with Key External Experts for meetings, participates in Health Canada advisory meetings and authors summaries for submission to Health Canada (as required).
• Influencing the global development of clinical trials and (investigational) products, representing the Canadian market, to mitigate regulatory risks in the development plans.
• Overseeing and participating in commenting and providing comments on emerging Canadian regulations/policies/guidelines/initiatives/surveys.
• Leading, coaching, and develop staff members to deliver regulatory outcomes related to clinical trial applications.

Essential Skills/Experience:

• Solid understanding of the Canadian regulatory environment and Canadian regulations, policies, and guidelines
• Strong experience with clinical trials and regulatory applications in one or more of the key therapeutic areas
• Minimum 3-5 years regulatory experience in the brand name pharmaceutical or biotechnology industries
• Minimum 2 years regulatory project management experience
• Proficient in the use of MS Office
• Superior negotiation skills, problem-solving ability, and innovative creative thinking
• Excellent time management and organizational skills
• Detail orientation to identify errors
• Strong written and verbal communication skills
• Ability to identify risk and build a plan to mitigate the risk
• Positive interpersonal and relationship-building skills

Desirable Skills/Experience:

• B.Sc or equivalent experience in a related (health science) subject area; advanced degree (M.Sc. or Ph.D.) is an asset
• Knowledge of international regulatory activities and trends
• Knowledge of AstraZeneca global and local policies and procedures
• Presentation skills

Summary:Great People want to Work with us! Find out why:Are you interested in working at AZ, apply today!AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing .Date Posted 19-Jul-2024Closing Date 02-Aug-2024AstraZeneca 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.

AstraZeneca