Regulatory Affairs Director

AstraZeneca • Mississauga, ON

1d • Hybrid

About The Position

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. As our Regulatory Affairs Director, you will provide strategic and operational regulatory leadership across the development, commercialisation and lifecycle management of our oncology portfolio. This is a senior, high-impact role for someone who wants to combine deep regulatory expertise with genuine cross-functional influence. As a core member of the Global Regulatory Strategy Team, you will bring US regulatory expertise to shape strategy at a global level. Working closely with the Global Regulatory Lead, you will support clinical development, lead agency interactions, and drive NDA and SNDA submissions — acting as the primary point of contact with the FDA for your assigned products. What makes this role particularly interesting is the variety it offers. Oncology drug development moves quickly, and projects span the full development lifecycle. You may find yourself supporting early development teams navigating novel compounds or combinations, addressing CDx challenges, or leading regulatory strategy for new clinical indications and marketing applications. There is always something new to work on and meaningful problems to solve. If you are looking for a role where your regulatory expertise has real strategic weight and direct impact on bringing innovative medicines to patients, we would love to hear from you.

Requirements

• Advanced degree in a scientific discipline, or equivalent relevant knowledge and experience.
• 10+ years’ experience in regulatory affairs within drug development, including expertise in at least one therapeutic area across both early- and late-stage development.
• Proven experience engaging with the EMA and other European regulatory authorities.
• Experience contributing to regulatory approvals, with additional experience leading response teams and supporting labelling negotiations considered advantageous.
• Demonstrated ability to think strategically and critically, with a strong track record of assessing regulatory risks, identifying opportunities, and guiding effective regulatory decision-making.
• Strong influencing and collaboration skills, with the ability to work effectively across cross-functional teams and build positive relationships with internal and external partners.
• Excellent written and verbal communication skills, with the ability to communicate complex regulatory issues clearly and effectively.

Nice To Haves

• Previous experience in oncology drug development.
• Good understanding of key principles of drug development, including benefit-risk assessment, dose selection, and statistical trial design.
• Broad experience within the pharmaceutical industry, including prior exposure to multiple areas of regulatory affairs. Experience within a relevant therapeutic area, including small molecules and biologics, would be advantageous.
• Ability to operate strategically within complex, business-critical, and high-profile development programmes.
• Strong critical thinking skills in relation to evolving regulatory science topics, with a solid understanding of the associated scientific and clinical considerations.
• Experience supporting Phase III study design, including participation in end-of-Phase II interactions with health authorities, would be beneficial

Responsibilities

• Lead the development and execution of the US regulatory strategy for one or more products, ensuring timely approvals and competitive labelling that align with business objectives, market needs, and patient benefit.
• Provide strategic leadership for interactions with FDA, including setting the regulatory approach, planning engagement activities, and ensuring briefing materials clearly reflect the agreed scientific and regulatory position. This includes leading team preparations, meeting rehearsals, and moderating agency meetings.
• Support the delivery of key regulatory milestones by providing expert US regulatory input into assessments of regulatory opportunity, risk, and mitigation strategies. Contribute to the development of regulatory strategy documents and target product labelling.
• Represent US regulatory perspectives within the Global Regulatory Strategy Team, ensuring regional requirements and considerations are effectively integrated into global development plans.
• Demonstrate strong strategic and team leadership to support effective product development, including coaching, mentoring, and providing performance feedback to members of the Global Regulatory Strategy Team.
• Oversee the planning and preparation of US dossiers and labelling, ensuring regulatory submissions are robust, compliant, and aligned with agreed strategy. Maintain accountability for post-approval product maintenance, supply continuity, and compliance activities for marketed brands.
• Collaborate with regional regulatory colleagues to help shape evolving regulatory positions and guidance across the region.

Benefits

• 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 respects of all aspects of the recruitment, assessment and selection process and may be requested by emailing [email protected].

What This Job Offers

• Job Type: Full-time
• Career Level: Senior