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Regulatory Affairs Director - Oncology

Location Mississauga, Ontario, Canada Job ID R-145324 Date posted 22/11/2022

Would you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines?

At AstraZeneca, we do this with the upmost integrity even in the most sophisticated situations because we are committed to doing the right thing! We continuously forge partnerships that help bring world-class treatments to patients in new ways, combining our people’s outstanding skills with those of people from all over the globe. Within Oncology Regulatory Science Strategy and Excellence (ORSSE), we bring hope and solutions to patients with unmet needs. We work across our ground-breaking pipeline and the business to get medicines to patients as efficiently and optimally as possible.

AstraZeneca in Canada

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.

To best support our employees in balancing personal and work commitments,we’ve embraced a hybrid model of working that gives employees flexibility in how they manage their time. 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.

Our Position

The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned oncology products. Serves as the global regulatory lead (GRL) on early stage projects or specific indications of larger programs and/or as the regional regulatory lead. The RAD plays a substantial role crafting and implementing the clinical strategy and influencing health authorities to improve outcomes.

What you'll do:

  • Lead cross functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority (HA) interactions, label discussions, and securing approvals.

  • Develop and implement the program's regional or global strategy ensuring that it is crafted to deliver rapid approval with insightful labeling that is identified by the business, markets and patients.

  • Craft the forward-thinking health authority engagement strategy and interaction plan, drive the formulation of the briefing document focused on strategy and scientific content, lead the team through meeting rehearsals and moderate the meeting itself.

  • Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team. Mentor, empower and provide performance feedback to members of your GRST.

  • Deliver sophisticated regulatory projects including an assessment of risks and mitigations, new insights, and the probability of success. Lead preparation of the regulatory strategy document and target product labeling.

  • Own discussions with health authorities and initiate and deliver key regulatory documents.

  • Plan and build the global dossier and core prescribing information including product maintenance, supply and compliance activities.

  • Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.

Minimum Qualifications:

  • Bachelor's degree in a science related field with at least 3 years of Regulatory strategy or related knowledge/experience.

  • A solid understanding of regulatory affairs within at least one therapeutic area in both early and late development, preferably oncology (small molecules & biologics)

  • Previous experience of regulatory drug development or equivalent, and experience with major HA interactions.

  • Demonstrated competencies of critical thinking, strategic influencing, risk evaluation, innovation, initiative, leadership skills and strong communication skills.

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

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.

Next Steps – Apply today!

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 follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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.

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