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    Lead Regulatory Affairs Director - Cambridge, United States - Aspartes Pharmaceuticals

    Aspartes Pharmaceuticals
    Aspartes Pharmaceuticals Cambridge, United States

    3 weeks ago

    Default job background
    Description

    Position Overview:


    We are seeking an exceptionally talented lead Regulatory Affairs director with a high level of experience in the rare/ultra-rare disease space.

    The role is centered around providing key insight and regulatory input for the development of a small molecule treatment for a rare-pediatric CNS disorder.


    This is a leading role, and you will act as the primary source for regulatory strategy and communication with the FDA as well as front the preparation and submission of regulatory applications and documents.


    Responsibilities:
    Providing early and late-stage regulatory leadership in the development and management of a rare pediatric disease product.


    Preparing, reviewing and submitting key regulatory documents and assessing opportunities for various applicable designations (Breakthrough, Fast-Track, RPD, ODD etc.) as a means to expedite the clinical trial and review process.


    Serving as the primary point of contact for strategic regulatory input on FDA meetings and negotiating with key regulatory agencies (FDA and Health Canada) to resolve and manage key regulatory hurdles.


    Requirements:


    In-depth knowledge of Regulatory Affairs strategies with an executive level of experience in the biotechnology and pharmaceutical industry with a focus on rare/ultra-rare disease and orphan drug development and the 505(b)2 pathway.

    Thorough understanding of FDA drug development regulations and guidelines.


    High level of familiarity working in the rare/ultra-rare disease space and knowledge of suitable pathways for expediting candidate products through clinical trials and approval.

    High level of ability to manage the preparation, submission and approval of regulatory IND/CTA/ODD/RPD applications

    Experience in interacting with regulatory authorities as needed for all aspects pertaining to drug development and regulatory approval.


    High level of experience in managing Breakthrough Therapy, Fast-Track, and Rare Pediatric Disease designation requests as a means of expediting the clinical trial process.

    Ability to negotiate with regulatory agencies to resolve key regulatory issues.

    Familiarity in organizing Expanded Access Programs, and implementing REMS strategies for products.


    We encourage you to apply by sending a detailed resume and cover letter detailing your relevant experience in regulatory affairs.

    Additionally, applications and qualifications can also be emailed to


    Job Type:
    Full-time


    Pay:
    $100, $200,000.00 per year


    Work Location:
    In person

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