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    Translational Regulatory Affairs Director - Mississauga, Canada - AstraZeneca

    AstraZeneca
    AstraZeneca Mississauga, Canada

    3 weeks ago

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    Full time
    Description

    At AstraZeneca, we foster a collaborative culture that promotes knowledge-sharing, encourages ambitious thinking, and drives innovation - providing our employees with the opportunity to collaborate across teams, functions, and locations worldwide.

    Our ways of working prioritize individualized flexibility, allowing employees to balance personal and professional commitments while fostering a culture of teamwork by engaging face-to-face in our offices three days a week. Our head office and BlueSky Hub in downtown Toronto are designed to facilitate collaboration, offering dedicated spaces for teams to strategize, brainstorm, and connect on key projects.

    At AstraZeneca, we are deeply committed to sustainability, an integral part of our culture that enhances our workplace environment. We understand the interconnectedness of human health, environmental well-being, and business success, which is why we are proactively addressing challenges such as climate change, healthcare access, and disease prevention.

    Within Oncology Regulatory Science and Strategy & Excellence (ORSSE), we have a team of brilliant minds driven by a shared passion for continuous learning, growth, and exploration. We are currently looking for a Translational Regulatory Affairs Director to join our diverse team based in Mississauga.

    The Translational Regulatory Science Director plays a pivotal role in providing strategic and operational regulatory guidance for the development, commercialization, and life cycle management of assigned products with a specific focus on translational areas. This includes identifying development opportunities that span across various functional teams and emphasize biomarkers or innovative approaches such as the utilization of novel endpoints or the integration of digital therapeutics.

    In this position, you will be responsible for formulating, aligning, and executing regulatory strategies to secure successful submissions and approvals with targeted labels for designated biomarker-driven development projects on a global scale. You will collaborate closely with cross-functional teams to ensure compliance with regulatory requirements for biomarkers and assays in oncology clinical trials, particularly focusing on cutting-edge biomarkers and technologies like ctDNA, computational pathology, and AI/ML throughout the biomarker development process.

    If you are a Regulatory professional with a deep-seated passion for Oncology and a drive to make a meaningful impact in the lives of cancer patients, we invite you to apply and become part of our dynamic team at AstraZeneca.

    Key Responsibilities:

    • Lead the formulation of global regulatory strategies to facilitate the progress of innovative biomarkers and associated assay technologies. Collaborate with project teams and various functions to seamlessly integrate these elements into regulatory risk assessment and mitigation strategies.
    • Develop and implement regulatory strategies to support the clinical advancement of biomarkers and assays, ensuring alignment with organizational goals.
    • Engage actively within cross-functional teams, contributing to decision-making processes concerning biomarker and assay-driven drug development inquiries.
    • Act as the Regulatory Affairs focal point on specified global project teams, providing strategic inputs and mentorship on crucial development and regulatory documents. Coordinate the review process to ensure scientific coherence and compliance with regional and global regulations.
    • Interact with major health authorities to optimize regulatory strategies and cultivate positive relationships.
    • Prioritize and lead preparations for meetings and discussions with local and global health authority officials, focusing on topics related to biomarkers and innovation.
    • Stay updated on pertinent regulatory policies and guidelines, discerning their implications for clinical and scientific operations.
    • Promote external engagement opportunities, contributing to relevant publications and participating in external speaking engagements to enhance the company's visibility and impact in the regulatory arena.

    Education, Qualifications, Skills, and Experience:

    Essential:

    • Advanced degree in life sciences or a related field.
    • Minimum of 5 years of experience in regulatory affairs or a related field.
    • Expertise in biomarkers and in vitro diagnostic (IVD)/companion diagnostic (CDx) regulations, with a comprehensive understanding of global regulatory frameworks.
    • Familiarity with biomarker innovations in oncology drug development, including AI/ML utilization and digital measurement tools.
    • Demonstrated track record of regulatory co-development of companion diagnostics with therapeutic products, with experience in engaging health authorities.
    • Thorough understanding of regulatory affairs in oncology across early and late-stage development phases.
    • Proficiency in critical thinking, influencing, innovation, leadership, and excellent oral and written communication skills.
    • Strong capabilities in communication, negotiation, and problem-solving.
    • Effective teamwork and multitasking skills.
    • Outstanding organizational and project management abilities with meticulous attention to detail.
    • Ability to work autonomously while upholding high-quality standards.

    Desirable:

    • Ability to work strategically within innovative, critical, and high-profile development programs.
    • Prior experience in oncology regulatory affairs, understanding the strategic and tactical aspects of global regulatory strategy in oncology drug development.
    • Technical expertise and comprehension of biomarker innovations such as AI/ML, computational pathology, or digital health.

    We attract exceptional individuals to work with us. Discover why.

    If you are eager to join the team at AstraZeneca, apply today.

    AstraZeneca upholds equal employment opportunities, prioritizing diversity and inclusion to create a discrimination-free workplace. We are dedicated to accommodating individuals with disabilities throughout the recruitment, assessment, and selection process upon request.

    Date Posted: 08-May-2024

    Closing Date: 06-Jun-2024

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