The Sr. Associate Regulatory Affairs will support the regulatory affairs team for both product and non-project initiatives. The candidate will support the Regulatory Affairs staff, ensuring that agreed upon work is executed and objectives are met within timelines and requirements.
In order to work effectively, the successful Sr. Associate Regulatory Affairs candidate should have a general understanding of the pharmaceutical/biotechnology industry. Experience with regulatory, quality, clinical, non-clinical, process & development or manufacturing is desired.
• Program management and meeting coordination for:
o Senior Global Regulatory Affairs Team
o Lead Innovation efforts and other initiatives
o Global and Local regulatory activities
o Submissions Project Management Office
o Preparation of regulatory portfolio and management presentations
o RegOps stakeholders meeting management (logistics and notes),
o Operations Forum monthly presentation
o SOP support for Doc Mgmt/Inspection readiness RA group - Operational and document management of SOPs,
o Develop and maintain key quality and performance indicators
o Support for other activities for Doc Mgmt/Inspection readiness RA group
o Budget and resource management preparation
o Creating and managing complex, integrated projects plans and Gantts
o Coordinating meetings, developing agendas, writing and issuing minutes and tracking action items
o Preparing and managing program documents and program status reports.
o Developing and managing program MS SharePoint content
o Provide creative and innovative ideas to move the Regulatory department forward to address current and future challenges
Minimum: BS (Biological sciences preferred)
2-5 years project management support experience and knowledge of the drug development process is required. Knowledge or background in Regulatory Affairs is preferred. The candidate should have exceptional oral and written communication skills and be fluent with software applications that will be regularly used (in particular Excel, MS Project Server, SharePoint and PowerPoint). Certification in project management (PMP, CAPM) is desired but not required.
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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.
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.