Regulatory Submissions Associate/Sr. Associate is responsible for activities related to regulatory publishing and submission support to fulfil GRA needs. Seeks to contribute into innovation process while supporting GRA strategy and deliverables. Ensures adherence to established business standards within GRA and cross- functional stakeholders. Collaborates with other global and regional development organizations, affiliates, and in-licensed partners to ensures that project/department milestones/goals are being met.
As an integral member of Otsukas regulatory operations team, provides regulatory publishing and submission support.
Ensures assigned submissions are made with quality and on-time.
Acts as primary liaison while coordinating regulatory publishing activities for all R&D functions.
Liaise with OPC-Japan for coordinating and publishing CMC-related content.
Owns delivery of electronic regulatory submissions to ensure processes are followed, as well as quality, budget and timelines are met in accordance with health authority requirements and Otsuka leadership established schedules.
Responsible for preparation, submission, tracking, and archival of paper and electronic submissions.
Assists with development of assigned regulatory operations work instructions.
Establishes and builds collaborative relationships with colleagues.
Represents Regulatory Submissions on various Process Mapping Teams (i.e., INDs, NDAs, Clinical Study Reports).
Responsible for organizing and maintaining regulatory files.
Provides regulatory publishing support to other departments.
Location - Candidate can either live a commutable distance from Princeton, NJ or Rockville, MD
Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for electronic and paper submissions.
Strong knowledge and experience in regulatory operations, including: formatting, publishing, submitting, lifecycling, and archiving (eCTD) sequences
Demonstrated performance in managing and producing time-intensive deliverables
Expert knowledge of Document Management Systems (Documentum preferred) and publishing tools (e.g., Lorenz DocuBridge, InSight Publisher, GlobalSubmit Validate, GlobalSubmit Review, and ISIToolbox)
Strong computer skills with demonstrated experience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and SharePoint.
Recent experience with NDAs (New Drug Application) / MAAs (Marketing Authorization Application) is essential
Demonstrated performance in managing and producing quality time-intensive deliverables.
Highly developed project skills
Proven ability to solve complex issues through innovative problem solving
Well defined written and oral communication skills
Knows how/when to apply organizational policy or procedures to a variety of situations
Demonstrates flexibility in dealing with change and diversity.
Ability to work effectively in a global, matrixed, multi-cultural, collaborative environment.
Successfully engaged in multiple initiatives simultaneously.
Bachelors of Arts or Science degree or equivalent professional experience Experience
Minimum 2 years for Associate-level (or minimum of 4 years for Sr. Associate level) of regulatory operations experience and in-depth first-hand experience with application electronic submissions.
Certification is a plus (such as Regulatory Affairs Professionals Society (RAPS).
Prior project management experience is preferred
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.