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    Regulatory Affairs Manager - Mississauga, Canada - AstraZeneca

    AstraZeneca
    AstraZeneca Mississauga, Canada

    3 weeks ago

    Default job background
    Full time
    Description

    Regulatory Affairs Manager, CVRM (Cardiovascular, Renal and Metabolism)

    Hybrid Work- on average 3 days/week from office

    Minimum 1 day from our Mississauga office and 2 days from our Mississauga or Downtown office

    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 is 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.

    What you'll do

    As a Regulatory Affairs Managers (RAM)within the CVRM therapeutic area, you will have a unique opportunity to work in cross functional teams, with all phases of drug development across geographic regions. With your knowledge, you will contribute to regulatory submission strategy, identify submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval.

    Accountabilities/Responsibilities:

  • Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
  • Provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including: Submission delivery strategy of all dossiers and all application types per market and /or region. Review of documents ( response documents, study protocols, PSRs, etc.). Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
  • Use and share standard methodologies, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.
  • Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of simple and with experience, increasingly more complex submissions throughout the product's life cycle from either a global and/or regional perspective.
  • Develop, implement and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated partners.
  • Coordinate the input, maintenance and revision in the Planit project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.
  • Identify regulatory risks and propose mitigations to Lead RPM and cross functional teams.
  • Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management using the support and input of GRO, MCs, CROs and/or alliance partners where relevant.
  • Provide coaching, mentoring and knowledge sharing within the RAM skill group.
  • Contribute to process improvement.

    • Essential Requirements– Education and Experience:

  • Relevant University Degree in Science or related subject area
  • Regulatory experience within the biopharmaceutical industry, or at a health authority, or other proven experience
  • General knowledge of drug development
  • Strong project management skills
  • Leadership skills, including experience leading multi-disciplinary project teams

    • Internal and External Contacts/Customers

  • Global Regulatory Leads (GRLs)
  • Regional Leads (eg, US, EU international RADs)
  • Lead RPM
  • Regulatory skill groups in ORSS, Late R&I and Late CVRM
  • Other R&D functions
  • Marketing Companies
  • Health Authorities
  • External collaboration partners

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

    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 .

    Date Posted

    27-May-2024

    Closing Date

    06-Jun-2024
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