Karyopharm Therapeutics Inc.

  • Senior Director, Regulatory Affairs

    Job Locations US-MA-Newton
    Job ID
    2019-1281
    # of Openings
    1
    Category
    Other
    Type
    Regular Full-Time
  • Responsibilities

    Responsible for actively contributing to the development and implementation of regulatory strategy for specific projects, executing submissions, serving as the regulatory lead on relevant project teams, and serving as the regulatory contact with relevant regulatory authorities, as appropriate.

     

    Working in partnership with the Senior Vice President, Regulatory Affairs:

    • Assist in work managing and executing regulatory submissions
    • Responsible for NDA & MAA submissions
    • Ensure regulatory compliance with pre- and post-approval filing and reporting requirements
    • Develop response strategies and submissions to regulators
    • Provide regulatory leadership and guidance to project teams, leadership for the development of global regulatory submission documents
    • Develop briefing packages, fast track applications, orphan drug applications for meetings with FDA and other global health authorities
    • Responsible for actively contributing to the development and implementation of regulatory strategy for assigned projects and programs. Contribute to the development and implementation of clinical and pre-clinical regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial)
    • Integrate global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents
    • Provide regulatory expertise and support nonclinical and clinical areas for investigational products
    • Ensure clinical and nonclinical programs are designed and implemented to meet regulatory requirements
    • Complete documents and other assigned tasks within established timelines and with high quality – in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes
    • Identify and assess regulatory risks for assigned projects or programs
    • Prepare and deliver effective presentations for external and internal audiences
    • Contact regulatory agencies relevant to assigned projects or programs, as appropriate
    • Participate and contribute in Health Authority meetings
    • Develop and mentor junior Regulatory staff members

    Qualifications

    • Minimum M.S. degree in life/health/technical sciences required
    • Minimum 10+ years’ regulatory experience or a PhD/PharmD or equivalent with at least 5 years of experience within the biotech or pharmaceutical industry
    • A minimum of 7 years regulatory experience within the drug development and approval process in IND/CTAs/Marketing Applications
    • Knowledge of global regulatory requirements
    • Experience preparing NDAs/MAAs, as well as experience within a matrix environment
    • Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals
    • Demonstrate excellent communication skills
    • Ability to represent the department in project teams
    • Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload
    • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
    • Demonstrated effective cross-cultural awareness and capabilities
    • Experience in interfacing with relevant regulatory authorities
    • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
    • Knowledge and understanding of applicable regulations
    • Experience in interpretation of regulations, guidelines, policy statements, etc.
    • Computer literate
    • Sensitivity for a multicultural/multinational environment

    Overview

    Karyopharm Therapeutics is a global commercial-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.

     

    Karyopharm Therapeutics Inc. (the "Company") is an equal opportunity employer.  All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law.  Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities.  If you require an accommodation in the application process, please contact a member of the Company’s Human Resources department.

     

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed