Associate Director, Regulatory Affairs-CMC

Regular Full-Time

Position Summary

Position Summary:          


Under the leadership of the Director/Senior Director, CMC Regulatory Affairs the incumbent manages the global regulatory CMC activities except Asia for all Taiho Oncology Inc., (TOI) projects, provides strategic CMC regulatory guidance during drug development, approval, post approval, and commercialization, in coordination with internal staff and external consultants/contractors. Manages the development and preparation of high quality CMC sections of the regulatory submissions including NDA's, MAA's, INDs, CTAs, DMFs, ASMFs, etc., and ensures that they conform to current GMP and global regulatory requirements. The incumbent interacts with regulatory authorities during the drug development and approval processes following an agreed upon plan.


Responsibilities and Duties:


  • Independently oversees as well as prepares global regulatory affairs activities for TOI with general guidance from the Director/Senior Director, CMC Regulatory Affairs.
  • Liaises with FDA and other regulatory authorities through correspondence, meetings, and teleconferences; strategizes and plans for FDA meetings. Interacts with FDA on submissions for CMC issues to ensure rapid preparation and approval of submissions and resolution of queries.
  • Fosters collaborative, efficient, and effective working relations with FDA (and other Health Authorities if necessary) in order to further build the cordial working relationship between Taiho Oncology, Inc. and FDA.
  • Manages, prepares, and compiles well organized scientifically sound CMC related regulatory submissions to ensure completion within project timelines and to satisfy global requirements and provides detailed risk assessments for regulatory submissions.
  • Evaluates changes control for determination of submission type and regulatory documentation requirements. Prepares reviews and compiles supplemental submissions to assure timely FDA approval.
  • Prepares CMC sections of regulatory filings, amendments, supplements and annual reports including the compilation and review of the required data, scientific reports and written submission contributions and ensures timely completion.
  • Serves as the regulatory CMC representative on core teams, develops and plans regulatory CMC submission strategy and proactively identifies CMC issues to pharmaceutical development and post marketing projects. Provides guidance to technical team members for the requirements and content of regulatory CMC documentation.
  • Assesses the impact on new regulations, guidances or enforcements and advise the project teams on requirements to maintain compliance with regulatory activities with emphasis on research and development activities.
  • Contributes to the development and implementation of Corporate and Department procedures to improve company performances and to align with regulatory requirements.
  • Prepare project and/or status reports as required.
  • This position requires 10-20% travel.


Educational Requirements:  


  • College degree in life science or health related or pharmaceutical field, or the equivalent.




  • Ten years of Pharmaceutical Industry experience including a minimum of 5 years of CMC regulatory or related experience with emphasis on Oncology products.
  • Experience in developing and implementing CMC regulatory strategy for early and late stage of development products with strong emphasis of approval through launch to post marketing commercial support
  • Previous experience managing CMC regulatory affairs functional areas and external CROs and consultants.
  • Substantial knowledge of and experience interacting and negotiating with regulatory agencies, particularly the FDA.

Other Skills and Abilities:

  • Strong working knowledge of global regulatory requirements and submission processes.
  • Good interpersonal skills that involves working well in a team environment and the ability to lead and influence others.
  • Collaborative skills
  • Good organizational and planning skills; results driven.
  • Excellence in written and oral communication.
  • Ability to reason, persuade and negotiate with regulatory authorities.
  • Ability to read, analyze and interpret scientific and technical information.
  • Effective analytical/problem solving skills.
  • Working knowledge of project management.
  • Ability to read, analyze, and interpret global regulations, scientific and technical journals and legal documents.
  • Ability to respond to inquiries or complaints from regulatory agencies.
  • Ability to write procedures.
  • Ability to effectively present information to internal and external clients.


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