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    Associate Director - Global Regulatory Lead

    Novo Nordisk
    8+ years
    Not Disclosed
    Plainsboro
    10 Jan. 8, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Global Regulatory Lead

    Location: East Coast Global Development Hub, Novo Nordisk
    Facilities: Lexington, MA, and Plainsboro, NJ

    About the Department

    Our East Coast Global Development Hub brings together the brightest minds in life science innovation, with facilities in Lexington, MA and Plainsboro, NJ. Supporting programs from early research through late-stage clinical development, we are focused on building a distinct R&D community rooted in collaboration, partnerships, and cutting-edge research across innovative modalities and therapeutic areas. This hub combines the agility of biotech with the quality, resources, and stability of a large pharmaceutical company. We are committed to developing new medicines for patients, improving human health, and changing lives. Ready to make a difference?

    The Position

    We are seeking a collaborative and science-driven global regulatory expert to lead a global regulatory team in developing and executing regulatory strategies for high-impact projects involving innovative investigational medicines. This leadership role will involve working with decision-makers across multiple functional areas to ensure the successful development of our products.

    Key Responsibilities

    Global Regulatory Strategy

    • Serve as a member of the Global Project Team (GPT), advising on development strategies and leveraging experience to innovate and achieve goals.
    • Lead the Global Regulatory Matrixed Team to define and execute global regulatory strategies, ensuring timely, high-quality regulatory deliverables.
    • Lead health authority interactions, preparing briefing materials and coordinating team efforts for meetings with health authorities.
    • Lead and support global filing activities for submissions.
    • Present regulatory strategies to management and internal stakeholders, including clear communication of risks and mitigation plans.

    Regulatory Review and Analysis

    • Oversee regulatory review of clinical and nonclinical documents (e.g., protocols, study reports, investigator brochures).
    • Research and analyze the evolving competitive and regulatory landscape to maintain up-to-date knowledge.
    • Effectively manage timelines in a fast-paced environment, navigating multiple time zones and cultures.

    Physical Requirements

    • 0-10% overnight travel required.
    • Ability to lift 0-10 lbs.

    Qualifications

    Education

    • Bachelor’s degree required; advanced degree preferred.

    Experience

    • Minimum of 8 years in pharmaceutical or related industry drug development.
    • Demonstrated knowledge of global regulatory requirements for drugs and biologics.
    • Proven ability to develop robust regulatory strategies.
    • Direct experience interacting with regulatory authorities on an international scale, including FDA.
    • Experience preparing teams for and leading meetings with regulatory agencies (including the FDA).
    • Experience with rare disease drug development, innovative trial design, and/or expedited regulatory pathways is highly desired.
    • Demonstrated ability to lead and motivate teams to meet shared objectives.

    Skills

    • Excellent verbal and written communication skills.
    • Strong organizational and problem-solving capabilities.
    • Ability to thrive in a busy environment and maintain a positive attitude under pressure.

    Equal Opportunity Employer

    At Novo Nordisk, we are committed to fostering an inclusive culture that celebrates diverse perspectives, backgrounds, and cultures. We are an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or veteran status.

    If you need special assistance or an accommodation to apply, please call 1-855-411-5290.

    Apply Now: Novo Nordisk Careers

    Together, we’re life-changing.

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