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.
Global regulatory submission/publishing experience, with advance knowledge of eCTD global submission dossiers, Agency and ICH Guidance. Experience in leading and managing regional submission activities for a major filing, (IND, NDA, sNDA, Amendments, DMFs, etc.) including the management of global submission timelines and coordination of publishing activities of work-related experience is needed for this position. Solid knowledge of submission requirements for regional global and emerging markets may be required to ensure the overall submission and quality of the dossier meets world-wide regulatory compliance.
Support Global System development and process development on a basic level, and process redesign. Conducts training on the submission process for current and new team members to support new requirements for eCTD Submissions and Data Standards mandated by the regulatory agency.
Submission Management Tasks:
- Lead and manage the submission dossier project management / coordination and work with team members to identify critical path of submission
- Track all relevant dossier component deliverables as needed to assure timely and high quality dossier by arranging submission team meetings.
- Serve as a resource for questions about the submission process.
Submission Project Management:
- Develop and manage the submission timeline with the regulatory affairs representatives; maintain the submission timelines; collect status updates from the Publishing Manager and IPT sub-team members, RA Leads; and report submission status and activities to various stakeholders.
- Maintain the regulatory affairs submission calendar, and reports on key submission milestones to stakeholders, as applicable.
Assist with hands-on daily submission compilation and publishing activities associated with preparation of various dossier types.
Business Processes Development:
- Identify resources and provide guidance for process updates to due changing regulations that impact submission strategies and technologies, SEND, CDISC, Validator Software, etc. This includes but is not limited to identifying the validation checks needed to ensure compliance with eCTD Specifications for world-wide regulatory agencies.
- Identify opportunities and advise management for process improvements or cost savings. May participate on internal project teams in order to guide and update business processes.
Process Development & Problem Solving Skills:
- Identify risks and opportunities and address as needed, focusing on customer satisfaction requirements by supporting best practices, Working Procedures and SOPs.
Identify opportunities and advise management for process improvements or cost savings. May participate on internal project teams in order to guide and update business processes.
· Bachelor's Degree required, or relevant work experience
· Five plus years of experience in a regulatory operations or regulatory affairs experience
· 5+ years experience regulatory professional that understands regulatory submission/ePublishing requirements for filing original applications, amendments, complex supplements/variations and line extensions, as well as routine submissions.
· Excellent communication skills required to interact effectively with regulatory affairs members and regulatory colleagues in gathering the necessary information required for submissions, and to proactively address sensitive issues with diplomacy and tact.
· Applies good judgment and demonstrates initiative to resolve issues.
· Advance understanding of Submission Project Management tools and techniques.
· Ensures submissions are processed in accordance with established SOPs.
· Manages multiple resources within and across groups to meet project deliverables with regard to regulatory requirements
· Leads problem solving: facilitating team(s) to identify issues and propose solutions with respect to regulatory issues
· Assists in resource allocation as needed to support regulatory activities
· Maintain a high level of expertise with projects through participation in internal meetings, including project training, and attendance at professional seminars and workshops.
· Previous line management experience.
· Maintain familiarity with current regulatory submission standards and industry best practices. Use knowledge gained from industry standards and evolving regulatory guidance to contribute to departmental best practices.
· Regional Regulatory Submission Knowledge: US Specific: Familiarity with FDA & ICH Regulations & guidelines, IND, NDA, sNDA, Amendments, Annual Reports, Orphan Drugs, Module 1 - Cover letter, forms, labelling & SPL, administrative information, Module 4 – STF, Module 5 –STF. Assumes overall global and regional responsibility for assigned product submissions. Canada submission experience is plus
· Ability to establish effective relationships with team members
· Ability to successfully prioritize and work on multiple tasks
· Ability to work in a team environment with changing timelines and priorities
· Effective written and verbal communication skills
· Demonstrated organizational skills, strong verbal and written communication skills, and attention to detail including proofreading
· Computer proficient in eCTD Publishing Software and document management systems
· Strong knowledge of Microsoft Office suite, Adobe Acrobat, Adobe Plug-Ins (e.g. ISIToolbox), electronic document management systems, eCTD publishing tools, eCTD validation and viewing tools
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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