At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
Development Projects
Assumes CMC regulatory accountability for clinical development documents (INDs, IMPDs, and CTAs) and agency communications (responses to questions) are prepared in compliance with the applicable regulatory requirements and scientific background
Identifies CMC regulatory issues and communicates them to the CMC team to mitigate risk
Prepares original BLAs, MAAs and Growth Market dossiers ensuring that quality documents are prepared
Tracks Module 3 leaf's for global submissions
Leads CMC authoring kick off meetings
Interacts with and influences external stake holders
Develops regulatory strategy
Post Approval Projects
Prepares CMC content of post approval supplements and variations globally; annual reports, product renewals, notifications and change supplements.
Tracks Module 3 leaf changes made as a result of post approval activity and submissions
Leads CMC authoring kick off meetings. Guides authors regarding the necessary Module 3 updates
Interacts with and influences external stakeholders
Evaluates proposed post approval changes and develops the regulatory strategy
Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, with minimum 8+ years of experience in the pharmaceutical industry e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance).
Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support for biological products
Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams.
Knowledge of CTD dossier (module 2.3 and 3).
Able to deal with issues of critical importance with minimal supervision. Provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance
Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork
Global organizational awareness
Excellent written and verbal communication skills
Leading change/innovative thinker
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
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