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    Regulatory Affairs Specialist - Los Angeles, United States - INTELLECTT INC

    INTELLECTT INC
    INTELLECTT INC Los Angeles, United States

    3 weeks ago

    Intellectt Inc background
    Description

    Position:
    Regulatory Affairs SpecialistLocation: Los Angeles, CAResponsibilitiesMaintain regulatory compliance of existing products for global customers.
    Manage regulatory compliance activities and customer product registrations.
    Provide strategic planning for regulatory changes.
    Act as the regulatory lead for site-specific activities such as Quality Reviews and Change Committees.

    Coordinate and prepare regulatory documentation for clinical trial applications, Drug Master Files (DMFs), medical device technical documentation, and registration CTD documents.

    Mentor and manage junior staff to achieve business and role objectives.

    RequirementsGraduate degree in pharmacy or a life science (or equivalent).Additional regulatory qualifications are advantageous.12-15 years of relevant experience in US, European, or Global registration procedures, or significant experience in other areas of the pharmaceutical industry.

    In-depth knowledge of the Global Regulatory Affairs environment, including guidelines and legislation.

    Deep practical knowledge of drug regulatory processes in the US and a background understanding of regulatory processes in other regions.

    General understanding of drug development and pharmaceutical manufacturing from concept to launch, including requirements for product development, manufacturing, and marketing, and the impact of regulatory changes on business goals.

    Broad understanding of the pharmaceutical business in general and other relevant associated regulatory areas such as Clinical Affairs, Medical Devices, and Chemicals Regulations.

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