Director Regulatory Affairs

US-NJ-Princeton
Requisition ID
2017-9690

Overview

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) discovers and develops new compounds that address unmet medical needs and advance human health. OPDC has numerous compounds in development to treat disorders in the neuroscience, oncologic, and cardio-renal therapeutic areas. OPDC is part of the Otsuka Group companies. For more information, visit www.otsuka-us.com.

Responsibilities

Provides regulatory expertise and support for pre-clinical and clinical areas for investigational and marketed products; develops and oversees the strategic implementations of electronic regulatory submissions processes and systems.

 

Ensures that development of drugs is in accordance with global regulations in order to approve drugs quickly and smoothly within typical approval timeframes. Ensures that marketed products are supported with minimal questions and issues from the regulatory agencies. Establishes well-defined regulatory pathways and creates accurate and timely documents for IND and NDA and global submissions and final approval.

  • Acts as liaison with the FDA for assigned investigational products, interacting with FDA personnel up to and including the Division Director level.
  •  Determines regulatory requirements for clinical and pre-clinical submissions to FDA for assigned investigational products.
  • Assures that Regulatory Affairs is adequately represented on project teams for assigned products.
  • Oversees and evaluates performance of assigned Managers (permanent and contractor) of Regulatory Affairs.
  • Researches regulatory information related to assigned projects, including reviewing Web sites and print material, and interfacing with other OPDC RA staff or external consultants.Interacts with other Directors/Senior Directors-Regulatory Affairs, CMC-Regulatory, Non-clinical Safety Evaluation, Clinical Management and Development, Program Management and Regulatory Submissions to ensure continuity for assigned investigational products.
  • Develops strategies, drafts responses, and/or reviews responses and documents intended for submission to FDA to assure compliance with regulatory standards.
  • Provides guidance to Project Teams on steps necessary to comply with regulatory legislation, regulations, and guidance documents.
  • Reviews documents/reports generated by RA Managers or other project team members to assess the likelihood that the content will meet pre-specified objectives, and provides input towards this end.
  •  Reviews and updates RA processes to ensure the efficient and timely flow of information among the project team.

Qualifications

Required:

PhD/MS/DVM/MD/BS with 7-10 years of relevant drug development or preferably regulatory experience in the pharmaceutical or health-related industry, Helpful to have 3-5 years of supervisory or management (direct or indirect) experience and experience negotiating internal and external drug development and drug product issues.

  RAC certification is a plus.

 

Knowledge: 

Requires strong working knowledge of the drug development process, drug laws, regulations, and guidelines.

Solid understanding of the FDA organization and ICH guidelines.

 

    Skills: 

Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).

Strong communication skills.

Excellent analytical skills and problem solving ability.

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