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    Senior Associate, Regulatory Lifecycle Management - North Chicago, United States - AbbVie

    AbbVie
    AbbVie North Chicago, United States

    3 weeks ago

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    Description

    Job Description

    Job DescriptionCompany Description

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

    Job Description

    Key Responsibilities

    • Responsible for monitoring the activity in Cosmos (the Regulatory Information Management system) for assigned portfolio products and ensuring the completeness and accuracy of RIM data in the Cosmos system.
    • Work with submission teams and provide appropriate guidance for managing the lifecycle of product submissions, applications and authorizations in Cosmos as described in functional area procedures.
    • Work within an electronic Regulatory Information Management (RIM) system (e.g. Cara Life Science Platform) to create product, application and authorization data for pharmaceutical, device and cosmetic products in alignment with defined data standards.
    • Determine system properties appropriate for the classification type/submission type of object desired by the business in Cosmos.
    • Utilize knowledge of regulatory submissions process.
    • Build submission and correspondence history within the RIM system for complex regulatory applications.
    • Elevate non-compliant records appropriately to the business user or regulatory admin for resolution using AbbVie change management expectations.
    • Responsible for educating internal customers on Regulatory information issues including commercial, public affairs, clinical development, legal, quality and others who contribute to RIM.
    • Extract data from the RIM system to address common regulatory reporting needs (e.g. Global Marketing Authorization report).
    • Review complex issues and problem resolution successes and setbacks to assist in future problem-solving applications/options.
    • Prepare routine communications for functional area and senior leadership as requested.
    • Execute business processes for activity type and product information management within Cosmos.

    100% telecommunicating permitted.

    Qualifications

    Bachelor's degree or foreign academic equivalent in Pharmacy, Biology, Chemistry, or a closely related field of study with at least 2 years of related experience in the following:

    1. experience working within an electronic Regulatory Information Management (RIM) system (e.g. Cara Life Science Platform) to create product, application and authorization data for pharmaceutical, device and cosmetic products in alignment with defined data standards;
    2. knowledge of regulatory submissions process;
    3. experience building submission and correspondence history within the RIM system for complex regulatory applications; &
    4. extracting data from the RIM system to address common regulatory reporting needs (e.g. Global Marketing Authorization report).

    Salary Range: $103, $153,000.00 per year.

    Apply online at Refer to Req ID: REF23808D.

    Additional Information

    We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term and long-term incentive programs.

    AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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