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    Director, Regulatory Affairs - Raleigh, United States - Azurity Pharmaceuticals - US

    Azurity Pharmaceuticals - US
    Azurity Pharmaceuticals - US Raleigh, United States

    4 weeks ago

    Default job background
    Description
    Direct the activities of US Labeling and Advertising/Promotional Review Teams. Responsible for the oversight of labeling for product registration and commercialization.
    Ability to provide Advertising/Promotional regulatory insight in line with applicable regulatory guidelines.

    Serve as a liaison and subject matter expert (SMA) on the interpretation of US Labeling and Advertising/Promotional FDA guidance documents and regulations.


    Duties & Responsibilities:
    Responsible for providing commercial regulatory strategy and leadership for promotional materials.

    Advise internal teams and management on regulations, guidance, and industry best practices related to product labeling and advertising/promotional components.

    Perform regulatory review of advertising and promotional materials, as required.

    Lead cross-functional teams to facilitate discussions regarding regulatory labeling submission strategies, required documentation and regulatory risks.

    Lead the MLR (medical, legal, regulatory) review committee for advertising and promotional components.

    Knowledge of submission process for promotional components to FDA's Office of Prescription Drug Promotion (OPDP).

    Excellent organizational, interpersonal, verbal, andwritten communication skills, strong grammar, andproofreading/editing skills, and MS Office skills are required.

    Knowledge of pharmaceutical labeling, packagingcomponents, graphic arts capabilities (ADOBEIllustrator/XML), and SPL labelingprocess.

    Track record of successfully working with third-partyvendors.

    Create/revise SOP's and Work Instructions as applicable, to ensure high performing regulatory operations and effective review processes.

    Continuously monitor the regulatory environment for new regulations, guidance, and enforcement.

    Recruit, develop and act as an advisor and coach to direct reports and junior members of the regulatory team.


    Ability to rapidly adapt to changing environmentand circumstances requiring flexibility, toleranceand great sense of urgency while ensuring that allcGMP and regulatory requirements aremet.


    Qualifications:
    Bachelor's degree in Life Science or other related discipline. At least 10 years' experience in Regulatory Affairs, with direct experience in Labeling and Advertising/Promotional review. A combination of education and applicable job experience may be considered.

    Experience leading team members, fostering a culture of efficiency and teamwork.

    Demonstrated track record of successful product launches.

    Strong expertise and knowledge of Advertising/Promotional regulations and guidance.

    Excellent organizational, interpersonal, verbal, andwritten communication skills, strong grammar, andproofreading skills.

    #LI-Hybrid

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