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    Director - Global Regulatory Lead

    Novo Nordisk
    10+ years
    Not Disclosed
    Lexington
    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 top minds in life science innovation, with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research to late-stage clinical development, building a distinct R&D community focused on collaboration, partnerships, and cutting-edge research across innovative modalities and therapeutic areas. This hub merges biotech speed and large pharmaceutical company quality, resources, and stability to develop new medicines for patients. We’re changing lives for a living. Ready to make a difference?

    The Position

    We are looking for a collaborative and science-driven global regulatory expert to lead a global regulatory team and develop regulatory strategies for high-impact projects involving innovative investigational medicines. You will work closely with decision-makers across multiple functions to ensure timely and high-quality regulatory deliverables.

    Key Responsibilities

    Global Regulatory Strategy

    • Serve as a member of the Global Project Team (GPT) to develop flexible approaches for achieving development goals and advising on strategies.
    • Lead the Global Regulatory Matrixed Team to execute the regulatory strategy for assigned programs, ensuring high-quality deliverables.
    • Lead health authority interactions, including briefing materials and meeting preparation.
    • Guide and/or support global filings for submissions.
    • Present regulatory strategies, including communication of regulatory risks and mitigation plans to management and internal stakeholders.

    Regulatory Review and Analysis

    • Supervise or conduct regulatory review of clinical and nonclinical documents for submissions (e.g., protocols, study reports, investigator brochures).
    • Research and analyze evolving competitive and regulatory landscapes to stay updated on trends.
    • Manage project timelines in a fast-paced environment, working across time zones and cultures.

    Physical Requirements

    • 10-20% overnight travel required.
    • Ability to lift 0-10 lbs.

    People Development

    • Ensure individual development plans (IDPs) are in place for reporting personnel, with annual goals and measurements aligned with business priorities.
    • Manage the communication and application of Novo Nordisk policies and procedures.

    Qualifications

    Education

    • Bachelor’s degree in a scientific discipline required; an advanced degree is strongly preferred.

    Experience

    • Minimum 10 years of experience in drug development, FDA, or regulatory industry.
    • In-depth knowledge of global regulatory requirements for drugs and biologics.
    • Proven ability to develop robust regulatory strategies.
    • Experience in interacting with regulatory authorities internationally, including FDA.
    • Experience in rare disease drug development, innovative trial designs, or expedited regulatory pathways is highly desired.
    • Demonstrated ability to lead and motivate teams to achieve joint objectives.

    Skills

    • Strong verbal and written communication skills.
    • Excellent 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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