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

    INTELLECTT INC
    INTELLECTT INC Los Angeles, United States

    2 weeks ago

    Intellectt Inc background
    Description
    Position: Regulatory Affairs Specialist

    Location: Los Angeles, CA

    Responsibilities

    • Maintain 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.

    Requirements

    • Graduate 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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