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 www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.
Provides regulatory strategy, planning and execution of investigational and marketed prescription drug submissions and lifecycle, working closely with cross-functional areas of the company. Applies regulatory intelligence and expertise to effect innovative regulatory pathways and solutions to complex global requirements.
- Develops the global regulatory strategy for all assigned R&D and marketed project(s) as the Global Regulatory Lead or in conjunction with the Global Regulatory Lead and subteam (regional leads, CMC-RA, labeling, medical writing, regulatory operations).
- Authors, coordinates, reviews, and executes increasingly complex submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs (as applicable) within company timelines and in accordance with regulations and guidelines.
- Interacts and manages internal/external functional business units effectively to gather data and develop documentation required for on-time submissions.
- Ensures submission documents are accurate, compliant, and high-quality to allow for smooth and expeditious approvals from regulatory authorities.
- Determines innovative and sound strategies in support of submission goals. Able to provide multiple options to address regulatory challenges and opportunities
- Represents RA with regulatory guidance/strategy/perspective in project team meetings and intermittently at senior leadership governance meetings as needed.
- Translates and presents pertinent evolving regulatory requirements to Global Regulatory teams and to internal/external functional business units as needed.
- Works closely with the Global Regulatory department to execute departmental initiatives to improve overall efficiency, quality, and/or output.
- Provide creative and innovative ideas to move the Global Regulatory department to address current and future challenges
- Bachelor's degree in life sciences, scientific, or engineering field.
- 5+ years of experience in Regulatory Affairs.
- Prior experience on at least one major marketing application (NDA/BLA/MAA/JNDA etc. or major supplemental application).
Prior experience working in the pharmaceutical and/or healthcare industry.
- 0-2 years of experience managing internal staff and/or external consultants.
- RAC certification.
Knowledge, Skills and Other experience
- Strong oral and written communication skills.
- Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc.
- Able to successfully interpret and apply regulatory intelligence to work output.
- Strong critical thinker with ability to work with uncertainties, analyze problems, and recommend innovative solutions.
- Results-oriented, entrepreneurial and self-motivated to learn and grow and and excellent organizational skills.
- Proactively manages and communicates issues, scopes, progress and risks throughout the project lifecycle ensuring key stakeholders are informed.
- Able to prioritize and work well in a fast-paced environment to multi-task, problem solve, and support the Global Regulatory Lead.
- Able to establish close communications and working relationship with cross functional teams to meet business objectives.
- Abiliity to generate problem solving innovative solutions.
- Strong demonstrated experience with Microsoft Office programs (Word, Excel, Powerpoint, Outlook) and familiar electronic document management systems (EDMS).
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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.