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    Regulatory Affairs Manager, Vaccines - Mississauga, Canada - AstraZeneca

    AstraZeneca
    AstraZeneca Mississauga, Canada

    3 weeks ago

    Default job background
    Full time
    Description

    About Us:

    Are you passionate about science and experienced in drug development and regulatory affairs? Would you like to combine your project management skills with your experience of working cross-functionally and globally?

    At AstraZeneca, we are fueled by innovation and our commitment to making a tangible impact on patients' lives. We are looking for individuals who share our enthusiasm for science and dedication to meeting patients' needs worldwide. Working here means embracing entrepreneurial spirit, thinking ambitiously, and collaborating to turn the impossible into reality. Does this align with your skills and aspirations for the future? Then come be a part of our team developing groundbreaking Vaccines and Immune Therapies for the prevention and treatment of infectious diseases.

    We are currently seeking dedicated professionals to join our Regulatory Project Management team as a Regulatory Affairs Manager (RAM). As part of our team, you will have the chance to work across the spectrum of drug development and advance a diverse pipeline.

    About the Role:

    The Regulatory Affairs Manager (RAM) is a global regulatory specialist with project management expertise responsible for overseeing/contributing to the end-to-end planning, coordination, and execution of assigned tasks. The RAM is accountable for timely, high-quality submissions that comply with relevant regulations. They play a key role in submission strategy, identifying risks and opportunities, leading submissions, and managing processes through approval. Additionally, the RAM offers regulatory guidance to teams working globally to ensure business goals are met.

    Role & Responsibilities:

    • Provide regulatory insights on procedural and documentation requirements mandated by Health Authorities for assigned tasks
    • Develop, implement, and update submission delivery plans, content plans, and provide status updates to stakeholders
    • Lead/contribute to the planning, preparation, and delivery of simple and complex submissions globally and regionally
    • Contribute to submission delivery strategy
    • Review documents for compliance with internal policies and regulations
    • Identify regulatory risks, communicate mitigation strategies, and understand the regulatory landscape for different application types
    • Offer coaching, mentoring, and knowledge sharing within the Regulatory Affairs Management team
    • Contribute to process enhancements for regulatory consistency
    • Ensure Regulatory compliance in designated markets/regions and escalate compliance issues

    Requirements:

    • Relevant University Degree in Science or related field
    • Regulatory experience in the biopharmaceutical industry, health authority, or related field
    • General knowledge of drug development
    • Strong project management capabilities
    • Leadership skills, including leading multi-disciplinary teams
    • Excellent written and verbal communication skills
    • Awareness of different cultures
    • Scientific knowledge to understand regulatory issues and facilitate discussions
    • Ability to work independently and collaboratively
    • Effective influencing and stakeholder management
    • Problem-solving and action recommendation abilities
    • Focus on continuous improvement and knowledge sharing

    Desirables for the Role

    • Managed regulatory deliverables across projects/products
    • In-depth understanding of the drug development process

      • Date Posted

      23-May-2024

      Closing Date

      13-Jun-2024
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