Senior Manager, Regulatory Affairs (Oncology)

Job title:

Senior Manager, Regulatory Affairs (Oncology)

Company

AstraZeneca

Job description

About Our Company:At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, daring 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 build a strong culture of collaboration and partnership by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely crafted 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 is an excellent place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking bold actions to address some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.Summary of Position:The Senior Manager, Regulatory Affairs (Oncology) is responsible for ensuring compliance with Company values, the AZ Code of Conduct, and relevant policies while fostering ethical conduct and team development. The role involves leading regulatory strategies to secure timely Health Canada approvals, maintaining compliance, and optimizing product lifecycle potential. Additionally, the Associate oversees daily operations within assigned therapeutic areas, manages resources, addresses customer needs, and supports the development of strategic plans to enhance AstraZeneca’s position in the Canadian market. The position also emphasizes coaching, mentorship, and fostering innovation to drive team and individual growth.What You’ll Do:

• Lead the development and implementation of regulatory strategic plans and oversee/lead submissions and negotiations with Health Canada to achieve regulatory approvals to meet business objectives.
• Ensure promotional materials, health professional communications, and press releases are aligned with corporate policies, regulatory requirements, and strategic objectives.
• Represent Canadian regulatory insights in global product development to mitigate risks and align with market needs.
• Drive innovative compliance practices in line with Health Canada and AstraZeneca standards while optimizing department-wide processes.
• Build and maintain strong relationships with Health Canada, Global Regulatory Affairs, AstraZeneca Canada teams, and Key External Experts to advance therapeutic area objectives and achieve positive outcomes.
• Oversee or lead coordination of responses to transparency requests (e.g., ATI, PRCI).
• Active member of the RA management team to ensure team collaboration, efficient day-to-day operations, process optimization, and budgeting/resource management.
• Stay updated on emerging Canadian regulations, policies, and guidelines, providing strategic insights to stakeholders.
• Adhere to Good Regulatory Practice and complete all mandatory training on time.

What We’re Looking For:

• 5–7 years of regulatory experience in the pharmaceutical or biotechnology industries, preferably with brand-name products.
• Advanced university degree (MSc or PhD) preferred.
• Expertise in Canadian regulatory environments, including Health Canada regulations, with knowledge of international regulatory trends.
• Strong cross-functional knowledge across Commercial, Market Access, Medical, and Operations.
• Deep therapeutic area, product, and brand management expertise.
• Proven leadership, emerging people management skills, and conflict resolution abilities.
• Exceptional project, time management, and organizational skills to handle multiple priorities.
• Strong analytical, problem-solving, and critical thinking capabilities.
• Excellent communication, negotiation, and influencing skills.
• Strong relationship-building and collaborative partnership abilities.
• Expertise in risk identification, management, and calculated decision-making.
• Customer-focused with a strong eye for business.
• Detail-oriented to ensure regulatory accuracy and compliance.

Who We Are:Great People want to Work with us! Find out why:At AstraZeneca, we are committed to investing in our employees’ growth and development. Our strength lies in our global, diverse network. We work seamlessly together, adapting and learning together to find new solutions that accelerate our impact. We value wellbeing and flexibility, creating an environment where everyone feels at home from the moment they join. We are trusted partners across the enterprise, driving growth through our niche expertise.Ready to make an impact? Apply now to join our team of specialists that is valued and essential to the growth of AstraZeneca!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 AZCHumanResources@astrazeneca.com ( ).Date Posted 08-Jan-2025Closing Date 22-Jan-2025AstraZeneca 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.

Expected salary

Location

Mississauga, ON

Job date

Thu, 09 Jan 2025 23:00:07 GMT

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