Karyopharm Therapeutics Inc.

  • Senior Manager, Regulatory Affairs

    Job Locations US-MA-Newton
    Job ID
    2018-1072
    # 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

    Responsible for acting as regulatory strategy lead for US and EU regulatory submissions (INDs, IMPD/CTAs and NDA/MAAs) including creating and maintaining regulatory trackers and timelines, management updates, scheduling team meetings, creating agenda, meeting minutes and conducting follow-up on action items with team members. The Senior Manager will act as the regulatory lead on clinical projects, contributing to the development and implementation of regulatory strategy, provide regulatory guidance on protocol design, IVD development, and serving as the regulatory contact with relevant regulatory authorities, including managing queries, meeting requests, responses, as appropriate.

     

    • Responsible for US and EU regulatory submissions including but not limited to IND/IMPD/CTA, NDA/MAA submissions, agency meeting briefing books and meeting minutes, orphan drug applications, special protocol agreement, fast track and breakthrough designation requests, PRIME submissions, orphan drug application, agency query sponsor responses.
    • Create and maintain regulatory submissions tracker and timelines, scheduling team meetings, agenda, meeting materials, minutes and follow-up with team members on action items.
    • Act as regulatory lead on clinical projects, 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.
    • Manage regulatory team members including assigning and prioritizing work while providing oversight and guidance to the team members
    • 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.
    • Contribute to the development of risk assessment pertaining to the quality-, safety- and efficacy documentation/data of investigational medicinal products related applications.
    • Research regulatory precedents on prior approvals, clinical endpoints, compare labels of competitors
    • Mentor junior Regulatory staff members.

    Qualifications

    • PhD or MS degree required, Life/Health Sciences preferred.
    • Minimum 8 years pharmaceutical industry experience, 5 years regulatory
    • Experience with regulatory submission procedures and regulations, preparation and writing regulatory documentation to support agency interactions
    • Experience in IND / CTA / eCTD requirements
    • Experience with maintenance activities of regulatory submissions to health authorizations in at least one region
    • Experience with supporting a project with development activities in at least one region
    • Strong project management skills including familiarity with PM toolkits.
    • Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
    • Demonstrate excellent written and oral 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.

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