Clinical Trials, Quality/Risk Management, Regulatory Compliance, Research & Development
Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since then we have rapidly grown to become a fully integrated pharmaceutical business. Eisai’s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company’s areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs.
Eisai recognizes that we are the Company’s greatest asset. To this, Eisai is committed to providing us an enabling and empowering work environment that allows us to grow and thrive. In our diverse organization, we adhere to a strict commitment to our values of Integrity, Respect, Professionalism, Quality and Teamwork. We therefore invite you to explore this job opportunity or any others that may match your qualifications and interests.
The Associate Director, Global Regulatory Affairs will contribute to the development of US and Global regulatory strategies for Eisai’s next-generation Neurology Portfolio from early development through post approval. This role will require: (1) careful understanding of current Regulatory environment (competitive intelligence and Health Authority guidance), (2) in depth planning with International Project Teams to ensure successful execution of INDs/CTAs/NDAs/MAAs, and most importantly, (3) frequent interactions with global Health Authorities to obtain agreement on the innovative strategies proposed to support getting these products to market expeditiously.
The Associate Director, Global Regulatory Affairs will foster drug development by facilitating the identification and resolution of scientific and regulatory issues with global Health Authorities such as the FDA, EMA and PMDA. The individual who assumes this role must possess the ability to work in a matrix organizational structure, show agility in problem solving and be able to work successfully with all levels of management.
The Associate Director will lead and contribute to the preparation and submission of INDs/CTAs/MAAs/NDAs/BLAs, responses to Healthy Authority requests for information and interact directly with global Health Authorities.
Primary Responsibilities Include but are not limited to:
• Assuming the role of Global Regulatory Lead (GRL) for assigned products in the Neurology Business Group Portfolio. • Leading the planning, execution and assessment of product life cycle management activities from early development through post approval • Proactively formulating regulatory strategies that provide for streamlined development and approval timelines, while accurately interpreting and reflecting regulatory and Corporate guidelines. • Leading the planning, preparation for and conduct of meetings with Health Authorities for all assigned products. Initiating and responding to Health Authority contacts to ensure expedient and efficient review and approval of products. • Leading creation of and ensuring all documents submitted to Health Authorities have been evaluated to ensure that they are complete, well organized, scientifically accurate, of high quality, and are in regulatory compliance as well as presented in a way that facilitates review. • Identifying, monitoring and resolving regulatory issues and reporting progress to management. • Guiding project teams to implement appropriate regulatory strategies and to assess regulatory support needs and align resources as Chair of the Global Regulatory Subteam. • Leading and coordinating all regulatory activities required for submissions to Health Authorities for assigned products.
JOB REQUIREMENTS: Here at Eisai, we are rewarded with highly competitive salaries, incentive awards, a comprehensive benefits package (Medical, Dental, Prescription and Vision Plans) 401k, Flexible Spending Accounts, Life and Disability Insurance, and other great programs.
Eisai is committed to a policy of equal employment opportunity for all employees and applicants. The Company also strives for a work environment free from discrimination and harassment. It is Eisai’s policy to comply with all applicable federal, state and local laws and regulations regarding nondiscrimination in employment and not to discriminate against any employee or applicant for employment on the basis of any protected status, including, but not limited to, race, color, national origin, religion, sex, age, disability, pregnancy, ancestry, creed, alienage or citizenship status, sexual orientation, gender identity and expression, marital status, military/veteran status, genetic information, or any other protected characteristic as established by law.
Eisai is an Equal Opportunity Employer – Minority / Female / Disability / Vet from tblHiringOrgDefaultshttps://eisai.contacthr.com/70341912.jpg />