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Director, Regulatory Affairs – Oncology

Location Mississauga, Ontario, Canada Job ID R-148665 Date posted 21/09/2022

Headquartered in Mississauga, Ontario, AstraZeneca has been recognized as a Greater Toronto Area Top Employer for eight straight years. We pride ourselves on creating a collaborative culture that champions knowledge-sharing, entrepreneurial 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 commitment 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 bold action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

Regulatory Affairs

Be part of a global, winning team filled with the most inquisitive minds. Our diversity is our strength, it reflects the variety of patients we serve. We strive to build a place where everyone is empowered to speak up and share ideas, and we encourage alternative perspectives to push our thinking further, together with patients in mind.

Regulatory Affairs Director – Oncology is responsible for leading the local regulatory activities related to oncology portfolio products and pipeline. The Regulatory Affairs Director – Oncology will deliver and maintain competitive licences for Canada including driving regulatory strategy for new initiatives. This individual will be responsible for ensuring regulatory compliance for defined product and project responsibilities, including project leadership and line management; timely delivery of clinical trial approvals and maintenance of high regulatory compliance standards for Canada achieved through provision of local regulatory expertise. This individual will support the development of AZ investigational and in-licensed/ co-development products through valued contributions to market consultation projects, regulatory Health Canada meetings and other related activities.

You will be responsible for:

  • Provide leadership and direction to the Oncology team to define and deliver corporate and functional objectives.

  • Lead regulatory processes for products within Oncology Therapeutic Area.

  • Proactively manage regulatory strategies and ensure effective negotiation with Health Canada to provide rapid and high quality regulatory approvals with competitive labelling and launch. Ensure desired outcomes are achieved that meet Canadian business priorities and regulatory and launch strategies.

  • Manage regulatory process for clinical trials and ensure timely delivery of clinical trial approvals and issue management.

  • Active member of the Oncology Leadership Team providing the organization with input and advice for the development and execution of regulatory strategic and tactical plans, issue management and people engagement.

  • Active member of the Regulatory, Patient Safety and Quality Assurance management team whose mandate is smooth, efficient day-to-day operations of the department, including contributing to department-wide process optimization, therapeutic area budgeting and resource management.

  • Lead and coach Oncology team enabling active learning, strong engagement, stretch goals, risk-taking, innovative thinking and career development.

  • Proactively impact Canadian legislation/regulations/policies/guidance's, including leveraging local Industry Association activities, assessing the impact of regulatory changes on business operations and direct the implementation of changes to meet new requirements.

  • Provide strategic and critical expertise on issues related to Oncology Therapeutic Area. For issues management, input on course of action and/or escalate line management when appropriate.

  • Develop and ensure effective working relationships with key external AstraZeneca partners (e.g. Health Canada, Key External Experts and Global Regulatory Affairs) to help drive positive decisions and to advance organizational objectives.

  • Oversee promotional and non-promotional reviews in collaboration with relevant stakeholders and ensure compliance with local legislation including transparency requirements.

  • Manager Accountabilities at AstraZeneca include Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, and Fiscal and Financial awareness.

Qualifications:

  • University degree in relevant scientific field. Advanced degree preferred

  • Minimum of 10 years of hand-on regulatory experience in the brand-name pharmaceutical/biologic industry

  • Multiple therapy area experience with knowledge of regulatory and quality requirements of small molecule and biological drug products. Desirable to have robust understanding of the disease and therapeutic area (oncology) including the regulatory and health technology assessment environment, competitive landscape, and predictable barriers/obstacles in development

  • Experience in creating and delivering regulatory strategies for accelerated review and collaboration review pathways

  • Validated people management skills

  • Demonstrated leadership skills and capabilities

  • Extraordinary influencing and negotiation skills and a proven track record of successful negotiations with Health Canada and local/Global partners

  • Sophisticated, innovative critical thinking

  • Excellent project management, time management and organizational skills (ability to lead multiple projects, teams and priorities effectively)

  • Confirmed communication (verbal, written, presentation) skills

  • Strong business insight

  • Risk identification and management, including ability to take calculated risks

  • Strong interpersonal and relationship building skills

  • Conflict management/resolution

  • Ability to facilitate collaborative teamwork: develop and/or lead cross-functional or external initiatives

  • Strong problem solving ability

  • Experienced, current knowledge and understanding of the Canadian Food and Drugs Act and Regulations, including Health Canada guidelines and policies, Good Manufacturing Practices, Health Canada (i.e. PDD, BRDD, MHPD, RORB) operations and governance and quality management systems

  • Experience with audits and inspections (Internal and Health Authority)

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

Are you interested in working at AZ, apply today!

AstraZeneca is committed to taking every reasonable precaution to protect employees, our customers and the healthcare systems in the communities in which we serve. In an effort to protect the wellbeing of our employees and customers, full COVID-19 vaccination is an essential requirement of all positions at AstraZeneca. As such, all offers of employment will be conditional upon either (i) proof of full COVID-19 vaccination or (ii) proof of need for accommodation under relevant human rights legislation, and AstraZeneca’s determination that the requested accommodation can be provided without undue hardship. You will be required to submit proof of full vaccination or proof of need for accommodation during our background screening process.

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 emailingAZCHumanResources@astrazeneca.com.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.