Deerfield Management Companies

  • Director of Regulatory Affairs

    Job Locations US-PA-Bala Cynwyd
    ID
    2019-1152
    # of Openings
    1
  • Overview

    The Director of Regulatory Affairs is intended to play a key role in the development of regulatory strategy and the plan for implementation for all products under development. This individual will also be responsible for overseeing the implementation of that plan. This role is the primary interface with global health authorities and represents the company in such interactions, along with relevant business leads. The individual will engage external consultants appropriately to develop the plan, working alongside internal and external stakeholders to ensure maximum and efficient value creation through creative and appropriate regulatory strategies.

    Qualifications

    • Minimum of 4-year undergraduate degree
    • Advanced Degree (masters or Ph.D) preferred
    • Advanced training in Regulatory Affairs required
    • 10 + years experience in a Regulatory Affairs role in the biotechnology industry
    • Demonstrated success in leading regulatory submissions and approvals
    • Understanding of GxP systems and quality principles
    • Demonstrated ability to interpret regulatory requirements into practice and to translate regulatory communications including “reading between the lines”
    • Demonstrated ability to work with business leads in a collaborative and supportive role
    • Demonstrated ability to think critically, identify and solve problems
    • Excellent communication, time management and project management skills
    • Continuous quality improvement mindset and attention to details
    • Can do attitude, flexibility, and mental agility

     

     

    Chondrial Therapeutics provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.

     

    PM18

     

    Responsibilities

    Job Duties/Responsibilities:

    • Serve as the lead on Regulatory submissions to FDA, working closely with the Manager of Regulatory and Quality Operations and external regulatory consultants to manage the submission strategy and plans and to ensure timely submissions
    • Advise project development teams on relevant regulatory requirements
    • Work with the Manager, Regulatory and Quality Operations to catalog and track all regulatory commitments and requirements, interpret such requirements and work with stakeholders to ensure they are met
    • Interface with FDA in FDA meetings, correspondence, and other communications
    • This position requires a close working relationship with subject matter consultants and internal experts to ensure the company maintains regulatory awareness and compliance
    • Maintains ongoing awareness of regulations and guidelines relevant to portfolio and areas of focus
    • Attends relevant FDA meetings to insure up-to-date knowledge of relevant regulations and current industry thinking
    • This role will be responsible for building out the regulatory organization as the company grows and expands its product portfolio

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