Karyopharm Therapeutics Inc.

  • Manager, Regulatory Affairs

    Job Locations US-MA-Newton
    Job ID
    2018-1206
    # of Openings
    1
    Category
    Other
    Type
    Regular Full-Time
  • Overview

    Karyopharm Therapeutics is a clinical-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.

    Responsibilities

    Position Summary:

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

     

    Duties and Responsibilities:

    • 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, pre-clinical and cmc regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial).
    • Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs.
    • 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.
    • Represent regulatory on relevant project teams.
    • Mentor other Regulatory staff members.

     

    Qualifications

    Qualifications:

    • Four-Year degree reequired, Life/Health Sciences preferred.
    • Minimum 3 years’ pharmaceutical industry experience, 2 years’ regulatory experience.
    • 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
    • Knowledge and understanding of applicable regulations.
    • Experience in interpretation of regulations, guidelines, policy statements, etc.
    • Computer literate.
    • Sensitivity for a multicultural/multinational

     

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