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Associate Director, Global Nonclinical Regulatory Affairs

Employer
Eisai
Location
07110, Nutley
Start date
Feb 12, 2024

View more

Discipline
Regulatory, Regulatory Affairs, Science/R&D, Toxicology
Required Education
Masters Degree/MBA
Position Type
Full time

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.

 

Job Summary

 

This position reports to the Executive Director, Global Nonclinical Regulatory and provides overall nonclinical strategic advice for product development and collaborates with colleagues in Global Drug Safety (GDS) to ensure nonclinical safety assessment programs for pipeline candidates meet evolving global regulatory standards. Formulates strategy and executes responses to nonclinical safety concerns from health authorities.

 

 

Essential Functions

  • Serve as eCTD Nonclinical Module Manager on assigned projects to ensure that high quality nonclinical sections of INDs/CTAs/NDAs/BLAs/MAAs and other global filings are provided according to submission timelines. (40%)

  • Lead the development of regulatory strategies to support the successful nonclinical development of pipeline products.  Implement strategies to identify, monitor, and resolve regulatory issues with moderate supervision (20%)

  • Partner with colleagues to optimize the global submission process and to address nonclinical safety issues.  Foster discussion of emerging issues and information sharing between Regulatory, GDS, and Clinical functions.  Collaborate with GDS colleagues to ensure nonclinical safety assessment programs for pipeline candidates meet evolving regulatory expectations. (10%)

  • Provide content and review regulatory documents prior to submission, including annual reports, DSUR, PSUR, RMP, GIB and CCDS.  Participate in formulating strategy and executing responses to nonclinical safety concerns from health authorities and draft nonclinical sections of briefing books as required.  Participate in face-to-face meetings with health authorities to contribute to the strategy toward effective progress of the projects and obtain mutual agreements with the Authorities. (10%)

  • Participate in initiatives to develop new Eisai policies that impact nonclinical regulatory affairs (10%)

  • Participate in nonclinical report finalization to ensure that the regulatory impact of findings are appropriately recognized and communicated. (5%)

  • Support Business Development in-licensing or out-licensing efforts (5%)

 

Requirements

  • Minimum MSc in life sciences.  PhD or DABT (Diplomat American Board of Toxicology) is preferred.

  • Minimum 8 years’ experience in the pharmaceutical industry, with a strong knowledge of regulatory toxicology

  • Experience preparing nonclinical regulatory dossiers and interacting with appropriate health authority regulators.

  • In-depth knowledge of appropriate regulations and regional and international guidance documents relevant to nonclinical safety assessment

  • Excellent communication skills, and the ability to build strong relationships in a highly matrixed organization.

  • Ability to think strategically, with an attention to detail.

  • Strong organizational and problem-solving skills

 

#LI_TS1

 

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.

 

Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

 

Right To Work

E-Verify Participation

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