The Senior Director, Regulatory Affairs provides regulatory expertise and support for pre-clinical, clinical, and commercial areas for investigational and marketed products. Ensures development of drugs are in accordance with global regulations in order to approve drugs quickly and smoothly within typical approval timeframes. Ensures marketed products are supported with minimal questions and issues from the regulatory agencies. Works with Regulatory Management to establish well-defined regulatory pathways and creates accurate and timely documents for IND and NDA submission and final approval.
Additional responsibilities include but not limited to the following:
General regulatory experience supporting pre-clinical to clinical domains for investigational products
Candidate will have specific digital health experience & the ability to shape policy in this space
Desire to pioneer new regulatory strategies and pathways within the digital space
Candidate who will proactively drive new regulatory policies by developing a strong relationship with key leaders at FDA and forging a true partnership with regulators
Resource that can see the entire landscape and negotiate across constituents and may even be able to build bridges between CDER and CDRH
Candidate would work closely with Strategic Partners product team to evolve product strategy as they work with FDA to impact policy so that we are a step ahead to keep product relevant
Resource should proactively monitor the federal register, understand the FDA position, work with internal stakeholders to craft Otsuka position, liaise with Strategic Partner to understand their perspective and negotiate across all stakeholders to our desired outcome (Strategist that can 1) evaluate our probability of technical & regulatory success (PTRS) 2) identify gaps in our label and 3) build an executable strategy to address those gaps
Individual who can work alongside medical/population health leader to build evidence to support the value prop
Minimum Bachelors degree with 12yrs industry related experience is required
Experience in regulatory affairs or related areas (e.g. clinical development, project management, quality assurance, etc.) within the pharmaceutical or healthcare industry is required.
Experience with Digital Medicine preferred.
Experience with FDA interactions, other health authority, or project meetings/ interactions is required
Comprehensive knowledge of the drug development process, drug laws, global regulations, and guidelines is required.
Proven success of submitted sNDA, IND and NDA required.
Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook) required.
Strong analytical skills, problem solving ability, communication and presentation skills required.
Up to 35% travel is required, based upon business needs.
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.