Regulatory Affairs Group Director, Late CVRM Regulatory Affairs

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – 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’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

About the Role

We are looking for a Regulatory Affairs Group Director (RAGD) for the Regulatory Affairs Management (RAM) group supporting the Cardiovascular, Renal and Metabolic Disease Areas. This group is part of Late CVRM Regulatory.

As RAGD you will be part of the RAM leadership team, responsible for line management of 7-12 regulatory professional staff. You will contribute to the strategy, direction and efficient operation of the Regulatory TA organization as well as the RAM community. Provide regulatory expertise and oversight to ensure high quality drug project operational delivery and efficiency by the group. You will also work on a drug project in a RAM role or drive continuous improvement or change projects.

Extensive regulatory affairs and drug development knowledge is critical, preferably with experience of leading major first wave submissions and leading complex regulatory procedures across projects/products. You will also possess strong leadership skills, have experience of developing teams, and excellent communication skills.

Other accountabilities will include

• Provide leadership, coaching and line management for a group of Regulatory Affairs Managers based in Mississauga
• Ensure efficient, targeted recruitment for the group and lead talent and performance development activities
• Collaborate with the RAM leadership team to set the strategy for tactical delivery and efficiency for drug projects
• Lead development and continuous improvement of expert and/or process area and/or work on a drug project
• Establish and develop relationships with key partners, internally and externally

Essential Requirements

• University Degree in Science or a related subject area
• Extensive regulatory affairs and drug development experience within the biopharmaceutical industry, or at a health authority
• Knowledge of regulatory requirements, procedures and legislation for drug development, throughout the product lifecycle
• Proven successful leadership and project management experience
• Excellent collaboration, teamwork, oral and written communication skills
• Strong influencing and negotiating skills.

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 11 years
• Top 100 Employers Award
• Canada’s Most Admired Corporate Culture
• Learn more about working with us in Canada
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We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.

AstraZeneca 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 authorisation and employment eligibility verification requirements.