Job Description

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, 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 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.

Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If so, please join us!

At AstraZeneca, we work with diverse minds, all united by a shared passion to learn, grow and discover.

Our Position

Within Oncology Regulatory Science and Strategy & Excellence (ORSSE) we bring hope and solutions to patients with unmet needs across the globe . As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible.

The Translational Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialisation and life cycle management of assigned product(s) with a specific focus on translational areas. Translational areas are development opportunities that take place in other functional teams than Regulatory Affairs and focus on biomarkers or approaches such as the development of ctDNA as a novel endpoint. This requires to anticipate early the potential regulatory impact and to develop the capabilities to design regulatory strategies applicable to late development projects, which meet regulatory agencies requirements. The Translational RAD develops interfaces between the functional areas involved in these projects, participate in the projects as a project team member, and help identify all necessary regulatory aspects that may benefit from interactions with regulatory authorities in the early stage of development or through an on-going development program. The role plays a key role in working closely with the RADs assigned to development programs and contributes to the development organizing regulatory authorities interactions dedicated to focused topics to be an integral part of a development program, e.g, ctDNA use in oncology drug development.

The impact of this position is high with implication on regulatory decisions, timelines and advancement for the company in contributing to the ORSSE "Roadmap" implementation.

Typical Accountabilities, what you will be doing:

Develop regulatory plans to support biomarker strategies (e.g. ctDNA), assay-driven strategies, and novel tools & approaches for the entire Oncology Portfolio. Develop and implement regulatory strategies for early cancer detection, minimal residual disease and early treatment interventions.

Develop global regulatory strategies to support the development of biomarkers, companion diagnostics, and other devices to enhance the value of oncology drug products.

Own the relevant regulatory activities by leading cross-functional teams of specialists and initiate and deliver key regulatory documents.

Provides strategic input on key development documents, clinical protocols, study reports, IBs, INDs, NDAs, BLAs, CTAs, IDEs, and PMAs for drug and diagnostic products.

Communicate and collaborate with cross-functional teams to facilitate biomarker-driven oncology drug development. Ensure global regulatory plans supporting translational and precision medicine approaches, e.g. integrated drug/diagnostic regulatory and submission plans, including health authorities (HA) engagement plans and mitigation strategies.

Ensure high quality collaboration with global regulatory leads and provides guidance to the regional strategists in strategic meetings with health authorities. May (depending on role and project) represent Regulatory Affairs on Global Product Teams (GPTs), provide strategic regulatory advice and be accountable for all regulatory activities.

Lead the objective assessment of emerging science, technology, and changes in the regulatory environment and advise senior management on project risks/mitigation activities accordingly.

As needed, develop and coordinate cross-functional workshops focused on translational regulatory topics.

Drive external engagement opportunities, and contribute to relevant publications, external speaking events.

Education, Qualifications, Skills and Experience:

Essential:

Bachelor's degree in a science related field with at least three years of Regulatory strategy or related knowledge/experience.

Previous demonstrated experience of regulatory drug development or equivalent, and experience with major Health Authority interactions.

A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development.

Demonstrated competencies of critical thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.

The ability to think strategically and critically and evaluate risks to regulatory activities.

Desirable:

Advanced degree is preferred.

Prior experience with phase 3 design including end of phase 2 health authority interactions is preferred.

A good understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design.

Prior experience of drug development tools (e.g. biomarkers, ctDNA) is preferred.

Understanding of scientific content and complexities of diagnostic development, including experience of IDE submissions and approvals is preferred.

Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Experience in relevant therapy area (small molecules & biologics) is preferred.

Ability to work strategically within a complex, business critical and high-profile development program.

Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical components.

Understanding of strategic and tactical roles and scope of Global Regulatory Strategy in the Drug and Device Development.

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

GTAA Top Employer Award for 8 years:

Best Workplace Culture Award at the 2018 Canadian HR Awards:

Learn about our culture:

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 a crucial 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 emailing .

Date Posted 21-Nov-2022

Closing Date 25-Nov-2022

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 authorization and employment eligibility verification requirements.