Manager, Regulatory Affairs Operations

US-NJ-Princeton
Category
Regulatory
Type
Regular Full-Time

Position Summary

Taiho Oncology, Inc. works urgently to discover and develop innovative cancer treatments. As cancer evolves, we evolve with it—bringing novel technology to cornerstone chemotherapies, while at the same time optimizing new targeted agents. Advanced technology, dedicated investigators, and incomparable facilities—these vast resources empower us to redefine the way the world treats cancer. It’s our work; it’s our passion; it’s our legacy. Under the leadership of Regulatory Affairs the incumbent manages global regulatory operational activities except Asia for all Taiho Oncology, Inc., (TOI) projects, provides strategic regulatory operational guidance during drug development, approval, post approval, and commercialization, in coordination with internal staff and external consultants/contractors. Coordinate the publishing and submission of electronic documents to regulatory authorities. Manages the operational aspects of eCTD filings, OPDP submissions and gathers Regulatory Intelligence for the broader Regulatory Affairs Group.

Responsibilities

  • Provide support to the Regulatory Affairs team in the creation, publishing and tracking of submissions and other regulatory documents in eDMS (Electronic Document Management System).
  • Prepares timely and accurate submissions of promotional materials to OPDP on Form 2253 via our electronic review process and system to adhere to Postmarketing FDA requirements for all approved products.
  • Build a strong relationship with internal customers such as: Clinical, Legal, Medical Affairs and Commercial.
  • Advise and support the Regulatory team in their preparation of scientific and regulatory documents for use in electronic regulatory submissions with regard to electronic requirements and formatting.
  • Support the development and implementation of procedures and processes for use of eDMS
  • Maintain a high level of knowledge of regulatory requirements for electronic submissions and industry trends and standards and remain current with evolving standards for electronic submissions.
  • Contributes to the development and implementation of Corporate and Department procedures to improve company performances and to align with regulatory requirements.
  • Assesses the impact of new regulations, guidances or enforcements and advise the Regulatory Group and TOI on requirements to maintain compliance with regulatory activities.
  • Fosters collaborative, efficient, and effective working relations with internal and external colleagues in order to further build the cordial working relationship between Taiho Oncology, Inc. and overall organization.
  • Prepare project and/or status reports as required.

Qualifications

Educational Requirements:  

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

 

  • 4 – 7 years of pharmaceutical industry experience in developing and implementing regulatory submissions strategy for early and late stage of development products with strong emphasis of approval through launch to post marketing commercial support.
  • Technical expertise in handling electronic document management system (EDMS) and OPDP Submissions.
  • Thorough knowledge of electronic Common Technical Document submission requirements
  • Self-organizing, self-directing, highly motivated with strong critical thinking and analytical skills.
  • 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 and good organizational and planning skills; results driven.
  • Excellence in written and oral communication.
  • 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 write procedures.
  • Ability to effectively present information to internal and external clients.

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