Associate Director Regulatory Affairs

Requisition ID


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.



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.



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

Solid understanding of the FDA organization and ICH guidelines.



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.


Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016. 

All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at Learn more about Otsuka in the U.S. at

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