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Deerfield

    Cco - Deerfield, IL, United States - Lundbeck

    Lundbeck
    Lundbeck Deerfield, IL, United States

    2 weeks ago

    Default job background
    Description
    At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. We have a robust and innovative pipeline, bringing forward transformative therapies to address unmet needs in neurology and psychiatry. Remote Opportunity - Open to candidates anywhere in the greater United States

    The Director, US Regulatory Affairs Global Strategic Labelling, oversees the process and compliance of the global labelling, including critical implementation of label as driver process and efforts to harmonize US and global processes, to ensure the successful development and approval of product labelling, as well as compliant lifecycle management.

    Collaborates with cross functional team to support implementation and control of labelling, and directs a cross functional resources to ensure global requirements and expectations are achieved in an optimal and compliant manner.

    Serves as LPLC chair, coordinating and collaborating with Global Strategic Labelling leadership and cross functional partners to ensure adherence to processes and procedures related to global labelling development, maintenance, and compliance.

    Provides regulatory expertise for the development and post-approval maintenance of global labelling, ensuring cross functional communication and execution per process.

    Partners with cross functional team to ensure development of target product labelling, as well as marketing registration labelling materials for the FDA and EMA.

    Responsible for the implementation and compliance management of the Company Core Data Sheet, in conjunction with Global Strategic Labelling team and cross functional support.

    Coordinates cross functional support to ensure compliance of global requirements.
    Liaises with Regulatory bodies regarding label development and change management.
    Provides high-level RA advice and identify regulatory requirements for labelling development and compliance.
    Assesses supporting information to support label language against regulatory requirements.
    Maintains awareness of global regulatory legislation and assess impact to marketed and development programs.

    Trains, develops, and manages an effective regulatory affairs cross-functional team on key labelling requirements (CMC, Regulatory Operations, US Labeling and Advertising and Promotion, International regulatory).

    Accredited Bachelor's Degree
    ~10+ years of experience within a pharm aceutical, medical device and/o r biotech industry, with 7+ years of experience in Regulatory Affairs
    ~3+ years of experience developing and maintaining labelling compliance for US, EU, and/or major market
    ~ Demonstrated team leadership and motivation of staff to successfully execute regulatory strategies.
    ~ Knowledge of development and registration timelines and requirements, to enable process management and compliance
    ~ Agile minded, with experience in global process improvement efforts
    ~ Seeker of innovative and creative solutions that comply with regulation but are also sound from a business and scientific perspective.
    ~ Ability to resourcefully direct the development of creative solutions to unusually complicated regulatory and systems problems.
    ~ Ability to influence division management at all levels to support regulatory compliance needs.
    ~ Accredited Bachelor's Degree in life sciences
    Doctorate Degree or MBA, other professional certifications.
    Exposure to international regulatory affairs, including participation in submissions to ex-US authorities


    TRAVEL:
    ~ Ability to travel up to 20% international travel may be required.

    Salary Pay Range:
    $ 200,000 - $235,000 and eligibility for a 25% bonus target based on company and individual performance , and eligibility to participate in the company's long-term incentive plan. B enefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Applications accepted on an ongoing basis. #LI-LM1, #LI-Remote

    Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life.

    Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process.

    If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation.

    We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.

    /*

    We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.



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