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    Regulatory Affairs Officer - New York, United States - Brio Group

    Brio Group
    Brio Group New York, United States

    2 weeks ago

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    Description

    Job Title:
    Regulatory Affairs Officer

    Company:
    Biopharma Organization

    Location:
    Hybrid, RTP Area


    Brio Resource Group is a Life Sciences Executive Search Firm committed to providing rare talent on an exclusive search basis to the Biopharma, Pharma, Device and CRO industries.

    We work on behalf of organizations that value true talent acquisition partners and specialize in supporting emerging Biopharma companies offering life-changing therapies and technologies.

    Our many years of experience, subject matter expertise, comprehensive search process and genuine passion to deliver rare talent defines Brio.


    Position Overview:

    • As a Regulatory Officer, you will be responsible for liaising with project teams, preparing regulatory submissions, tracking project documentation, acting as the contact for regulatory matters, and assisting with client presentations on regulatory aspects.

    Opportunity Highlights:
    Serve as contact person for regulatory issues and assist with client presentations
    Maintain regulatory database and review INDs
    Track regulatory documentation flow and progress
    Prepare regulatory and ethics dossier submissions
    Procure documents for regulatory and ethics submissions, including import/export licenses


    Preferred Qualifications:
    Bachelors Degree Required
    3+ years of experience in Regulatory Affairs submissions
    Strong expertise in IND lifecycle management and submissions
    Skilled in Regulatory Publishing, eCTD, and interacting with regulatory authorities
    Proficient in MS Office, detail-oriented, collaborative, and strong communication skills

    We welcome the opportunity to provide a full job description upon resume review.


    How to Apply:
    In order to be considered for the above opportunity, simply apply via LinkedIn and include your CV.


    We respond to applicants who meet our position requirements, but suggest submitting your resume for future consideration for our expanding list of new opportunities surfacing daily within our Biopharma network.

    We have a strict honor code at Brio respecting your confidentiality and we only share your information with your consent.


    Brio Resource Group, LLC considers all applicants without regard to race, color, religion, sex, national origin, age, mental or physical disabilities, or any other similarly protected status.

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