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    Regulatory Affairs Manager - Toronto, Canada - Pharma People

    Pharma People
    Pharma People Toronto, Canada

    1 week ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Role Overview:

    This position entails overseeing project management within Regulatory Affairs for both emerging and established products.

    Responsibilities:

    Provide strategic and operational regulatory guidance to teams locally and globally across product lifecycles.

    Develop and implement filing strategies, evaluating scientific and clinical data as needed.

    Arrange and manage meetings with relevant regulatory authorities.

    Ensure the timely preparation of regulatory submissions adhering to internal strategies and Health Authority Regulations.

    Participate in cross-functional meetings, offering expertise on product strategies.

    Maintain ongoing compliance for marketed products, including updates to product monographs and labels.

    Review and approve promotional and non-promotional material in accordance with regulatory standards.

    Manage internal databases for product portfolios.

    Requirements:

    Change leadership skills, with the ability to adapt and prioritize effectively.

    Strong strategic and analytical thinking abilities.

    Capable of managing and influencing key stakeholders.

    Strong submissions experience.

    Openness to innovation and new processes.

    Ability to work independently and collaboratively.

    Bachelor's degree in a health-related field.

    5+ years of Regulatory Affairs experience, demonstrating success in regulatory environments.

    Proficiency in current regulatory regulations and guidelines.

    Development project management.

    Cross-functional experience.

    Language Skills:

    Proficiency in English (written and spoken). Other languages would also be a plus, though not mandatory.

    Computer Skills:

    Proficiency in MS Outlook, PowerPoint, Word, Excel, and Adobe Acrobat.

    Familiarity with Veeva Vault database is preferred.

    Travel:

    on an occasional basis.

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