At Astra

Zeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation ultimately providingemployees 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 Blue

Sky 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 Astra

Zenecaa great placeto work.

We know the health of people, the planet and our business areinterconnectedwhich is whyweretaking 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,commercialisationand lifecycle management of our oncology portfolio.

This is a senior, high-impact role for someone who wants to combine deep regulatoryexpertisewith genuine cross-functional influence.

As a core member of the Global Regulatory Strategy Team, you will bringUSregulatoryexpertiseto shape strategy at a global level.

Working closely with the Global Regulatory Lead, you will support clinical development, lead agency interactions, and driveNDAandSNDAsubmissions acting as the primary point of contact with theFDAfor 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, addressingCDxchallenges, or leading regulatory strategy for recent 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 regulatoryexpertisehas real strategic weight and direct impact on bringing innovative medicines to patients, we would love to hear from you.

Lead the development and execution of theUSregulatory strategy for one or more products, ensuringtimelyapprovals and competitive labelling that align with businessobjectives, market needs, and patient benefit.

Provide strategic leadership for interactions withFDA , 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 expertUSregulatory input into assessments of regulatory opportunity, risk, and mitigation strategies.

Contribute to the development of regulatory strategy documents and target product labelling.

RepresentUSregulatory perspectives within the Global Regulatory Strategy Team , ensuring regional requirements and considerations are effectively integrated into global development plans.

Lead the development and execution of theUSregulatory strategy for one or more products, ensuringtimelyapprovals and competitive labelling that align with businessobjectives, market needs, and patient benefit.

Provide strategic leadership for interactions withFDA , 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 expertUSregulatory input into assessments of regulatory opportunity, risk, and mitigation strategies.

Contribute to the development of regulatory strategy documents and target product labelling.

RepresentUSregulatory 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 ofUSdossiers 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 positionsandguidance across the region.





Essential Skills/Experience Advanced degree in a scientific discipline, or equivalent relevant knowledge and experience. 10+ years experiencein regulatory affairs within drug development, includingexpertisein 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, withadditionalexperience leading response teams and supporting labelling negotiations consideredadvantageous.

Demonstrated ability to think strategically and critically, with a strongtrack recordof assessing regulatory risks,identifyingopportunities, 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 complexregulatory issues clearly and effectively.

Desirable Skills/Experience: Previousexperience in oncology drug development.

Good understanding of key principles of drug development, including benefit-risk assessment, doseselection, 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, includingsmall molecules and biologics, would beadvantageous.

Ability tooperatestrategically 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 inend-of-Phase II interactions with health authorities, would be beneficial Great People want to Work with us! Find out why: This is the place to make a meaningful impact on patients lives and your personal growth.

Its both exciting and inspiring, and its what keeps us motivated every day.

Astra

Zeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination.

Astra

Zeneca is committed to accommodatingpersonswith 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.

Ready to make a difference? Apply now! We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.

📌 Regulatory Affairs Director (Mississauga)
🏢 AstraZeneca
📍 Mississauga