Radius Health, Inc.

  • Director, Regulatory Affairs Oncology

    Job Locations US-MA-Waltham
    Posted Date 1 month ago(4/19/2018 3:32 PM)
    Job ID
    2018-1757
    # of Openings
    1
    Category
    Regulatory Aff - Dept
  • Overview

    The Director, Regulatory Affairs Oncology (Elacestrant and RAD-140) will develop and implement effective regulatory and related strategies for the development and commercialization of Radius products. The incumbent will ensure adequate planning and accurate data for the earliest possible approvals of products, taking into account both U.S. and international regulatory requirements.

    Responsibilities

    • Develops content and format for regulatory submissions, such as Investigational New Drugs (INDs), Market Authorization Applications (MAAs), New Drug Applications (NDAs), related supplements and amendments as well as clinical protocols.
    • Advises and oversees internal personnel regarding the development and implementation of regulatory strategy through non-clinical, clinical, manufacturing, and other processes.
    • Oversees preparation, submission, application, and routine reports including preparation of amendments and supplements as required by internal departments.
    • Sustains excellent relationships with regulatory agency personnel. Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly with regulatory authorities regarding company’s filings.
    • Develops, implements, and reviews current policies and practices issued by Federal and international regulatory agencies.

    Qualifications

    • Requires a BS degree or equivalent with a Master’s degree or PhD preferred.
    • Required 10 years related experience within the biotechnology/pharmaceutical industry along with 8 years of clinical regulatory experience or equivalent combination of education and experience.
    • Has significant experience with oncology products and in leading meetings with the FDA Oncology division.
    • Has experience with programs leading to accelerated approval.
    • Successful completion of an NDA and MAA application(s).
    • Working knowledge of eCTD submissions and supportive technologies.


     

    Work Environment:

    The work is performed in a typical office environment with heavy computer duties.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The noise level in the work environment is usually quiet.   Frequent travel required.

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents.  The employee is occasionally required to stand and walk.  The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. 

    Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.

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