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    Senior Manager, Regulatory Affairs - Honolulu, United States - Fresenius Kabi USA, LLC

    Fresenius Kabi USA, LLC
    Fresenius Kabi USA, LLC Honolulu, United States

    1 week ago

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    Description


    Job Summary The Senior Manager, Regulatory Affairs position will support the Regulatory Affairs (RA) Director to help define the regulatory strategy for our innovative next-generation technology for cellular therapy.

    This position will play a substantial role researching regulations, defining and implementing the regulatory strategy and engaging with health authorities to effectively inform our development programs.

    The successful candidate should possess a scientific background and will have an understanding of the unique aspects of cell therapy.

    The ability to deal with ambiguity and think outside the box are critical for this position.

    *While this position can be worked remotely, qualified candidates must reside in the U.S. and be permanently authorized to work in the U.S. Responsibilities


    Work under the director of the RA Director to craft the health authority engagement strategy and interaction plan, drive the formulation of the meeting package, lead the team through meeting rehearsals (if needed) and may moderate the meeting itself.

    Prepare, review, compile, and archive regulatory submissions and correspondence.

    Submission types can vary, may include:

    Investigational New Drug (IND) applications, Biological License Applications (BLA), Regenerative Medicine for Advanced Therapy (RMAT) Applications, Investigational Device Exemption (IDE), 510(k), and other submissions as necessary.

    Work with RA partners at stakeholder organizations to further refine the overall RA strategy.
    Ensure project teams, deliverables and business objectives are aligned with RA strategy.
    Provide strategic and technical input for regulatory decisions.
    Respond to regulatory agency questions within defined timeline.
    Monitor emerging regulation changes which have the potential to impact these products and identify impact or solution.
    Job Requirements
    Bachelor's Degree required with 8+ years of experience in a regulatory function.
    2+ years of experience in Cell Therapy.
    Demonstrated experience in regulatory filings and support for CGT/ATMP products.
    Ability to work strategically within a business critical and high-profile development program.
    Experience in preparing regulatory submissions, such as INDs and BLA/NDA.
    Proven effective collaboration with regulatory agencies.

    A solid knowledge of regulatory affairs, including proven track record of regulatory drug development and experience with major health authority interactions.

    Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical component.

    Established working knowledge of regulatory guidelines and regulations including Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines (e.g., ICH, FDA and EMA guideline).

    Additional Information

    We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance,

    disability,401K

    with company match, andwellness program.
    Fresenius Kabi is an Equal

    Opportunity/Affirmative

    Action employer.

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

    #J-18808-Ljbffr
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