Regulatory Affairs Director

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**

At AstraZeneca, we pride ourselves on crafting 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 dedication 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 ambitious 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**:

- GTAA Top Employer Award for 9 years
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