Translational Regulatory Affairs Director
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.
Within Oncology Regulatory Science and Strategy & Excellence (ORSSE), our team is made up of intelligent minds, all united by a shared passion to learn, grow and discover. We are seeking a Translational Regulatory Affairs Director to be a part of our diverse team located in Mississauga.
The Translational Regulatory Science Director provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned product(s) with a focus on translational areas. These areas include development opportunities that take place in other functional teams and focus on biomarkers or approaches including the development of novel endpoints or the introduction of digital therapeutics.
In this role, you will be responsible for developing, aligning, and implementing regulatory strategies to ensure successful submissions and approvals with target labels for assigned biomarker-driven development projects on a global scale. The successful candidate will work closely within cross-functional teams to ensure that regulatory requirements of the biomarker and assays in oncology clinical trials, especially innovative biomarkers and technologies (e.g., ctDNA, computational pathology, AI/ML) are met throughout the biomarker development process.
If you are a Regulatory professional with a passion for Oncology and want to make a difference in the lives of cancer patients, please apply to join our team at AstraZeneca.
Typical Accountabilities:
- Lead the development of global regulatory strategies to facilitate the advancement of innovative biomarkers and associated assay technologies. Collaborate with project teams and other functions as vital to ensure seamless integration of these elements into regulatory risk assessment and mitigation strategies.
- Develop and implement regulatory strategies to support the clinical development of biomarkers and assays, ensuring alignment with organizational objectives.
- Work closely within cross-functional teams, actively participating in decision-making processes related to biomarker and assay-driven drug development queries.
- Serve as the Regulatory Affairs representative on designated global project teams, offering strategic insights and mentorship on key development and regulatory documents. Coordinate the review process, ensuring scientific coherence and compliance with regional and global regulations.
- Engage with major health authorities to optimize regulatory strategies and maintain positive relationships.
- Prioritize and lead preparations for meetings and teleconferences with local and global health authority officials, focusing on biomarker and innovation-related topics.
- Keep abreast of relevant regulatory policies and guidelines, understanding their implications for clinical and scientific practices.
- Drive opportunities for external engagement, contributing to relevant publications and participating in external speaking events to improve the company's visibility and influence in the regulatory landscape.
Education, Qualifications, Skills, and Experience:
Essential:
- Advanced degree in life sciences or a related field, such as Ph.D., Pharm.D., or M.Sc.
- Minimum of 5 years of experience in regulatory affairs or a closely related field.
- Expertise in biomarkers and in vitro diagnostic (IVD)/companion diagnostic (CDx) regulations, with a detailed understanding of global regulatory frameworks.
- Knowledgeable about biomarker innovations in oncology drug development, such as the use of AI/ML and digital measurement tools.
- Proven track record of regulatory co-development of companion diagnostics with therapeutic products, with experience in engaging with major health authorities.
- Solid understanding of regulatory affairs in oncology throughout both early and late-stage development.
- Demonstrated proficiencies in critical thinking, internal and external influencing, innovation, initiative, leadership, and outstanding oral and written communication skills.
- Strong abilities in communication, negotiation, and problem-solving.
- Proficiency in working effectively within cross-functional teams and managing multiple priorities.
- Excellent organizational and project management abilities, with keen attention to detail.
- Capacity to work autonomously while maintaining high-quality standards.
Desirable:
- Ability to work strategically within innovative, sophisticated, business critical and high-profile development programs.
- Prior experience with oncology regulatory affairs; understand the strategic and tactical roles and deliverables of global regulatory strategy in oncology drug development.
- Technical experience and understanding of biomarker innovations such as use of AL/ML computational pathology, or digital health would be advantageous.
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Are you interested in working at AZ, apply today!
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.
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 authorisation and employment eligibility verification requirements.
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