The Manager, Regulatory Affairs serves as regulatory representative to Project Teams for assigned projects or products and provides regulatory tactical support and strategy. Liaises with regulatory agencies in order to expedite approval of pending registration and answer questions. Ensures that clinical trials meet regulatory requirements as designed. Prepares and ensures rapid and timely submission of new drugs and maintain applications to sustain approved status of marketed drug.
Recommends guidance to Project Teams on steps necessary to comply with newly enacted regulations and guidelines.
Recommends regulatory requirements for clinical and pre-clinical submissions to FDA for assigned investigational and marketed products.
Conducts regulatory research and intelligence to appropriately guide Project Teams.
Responsible for the overall quality of regulatory submissions. Manages, Reviews and organizes documents intended for submission to FDA to assure compliance with regulatory standards. Provides appropriate regulatory guidance to Project Teams for the development of the above regulatory submissions.
Interacts with Project Managers at FDA (pre and post submission).
For assigned projects, provides effective oversight for regulatory submissions that are outsourced.
Extensive knowledge of drug development process.
Solid understanding of medical and clinical practices
Strong understanding of medical concepts and terminology, including strong knowledge of FDA Part 11 and global regulations
Knowledge of CFRs, ICH and FDA regulations
Strong knowledge of submission preparation and management
Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook) and Adobe Acrobat
Strong communication skills
Knows how/when to apply organizational policy or procedures to a variety of situations Travel 10-20%
Education and Related Experience
PharmD, PhD plus minimum 2 years of pharmaceutical industry experience in regulatory affairs. OR
BS degree with minimum 5 to 7 years of pharmaceutical industry in regulatory affairs
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 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 50,000 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 www.otsuka.co.jp/en . Learn more about Otsuka in the U.S. at www.otsuka-us.com .
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
At Otsuka, our people are passionate about developing and delivering original products as part of a global holistic commitment to better health and well-being. We have two core businesses dedicated to achieving our goals: a pharmaceutical business and a nutraceutical business. The pharmaceutical business develops and markets products for the diagnosis and treatment of disease in the following areas: central nervous system, oncology, gastroenterology, ophthalmology and cardiovascular. The nutraceutical business is dedicated to maintaining and improving health through the use of foods and beverages that provide extra health benefits in addition to their basic nutritional value. Since the beginning, nearly 100 years ago, the Otsuka family sought to develop products that stood out from the crowd, by traveling down the paths of discovery where others were less likely to tread.
We believe our culture and our people are the differentiators that empower us to produce breakthrough results. This is what makes us a big venture company that takes risks and focuses on unmet medical needs in order to develop new and better therapeutic compounds. We harness the extraordinary cr...eative and innovative abilities of our people to solve problems differently, and to persevere until they find answers. We are in this for the long-haul. Otsuka is a highly ethical company. We adhere to the highest standards in how we develop and deliver our products, and in how we treat our most valuable assets: Otsuka-people. We encourage them to follow their dreams, as turning dreams into reality is at the core of everything we do. It paves the way ahead to achieve our shared purpose: impacting on human health to help people live better lives.