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Senior Regulatory Affairs Scientist

Employer
City of Hope
Location
Duarte, California
Salary
Competitive
Closing date
Oct 12, 2019

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Discipline
Life Sciences
Position Type
Full Time
Organization Type
Healthcare/Hospital

Job Details

About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 6,000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.

Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation's leading cancer centers that develops and institutes standards of care for cancer treatment.

Position Summary

The Senior Regulatory Affairs Scientist is an integral part of the newly created Translational Development Center (TDC) in the City of Hope (COH) Research Operations and will work under the direction of Dr. Rodica Stan. The Senior Regulatory Affairs Scientist is a critical institutional resource that is primarily responsible for assisting investigators engaged in TDC projects with all Regulatory Affairs aspects of their projects. This includes the preparation and writing of regulatory documents, such as pre-IND submission letters and packages, Investigational New Drug Applications (INDs), IND exemptions, and IND Amendments and Annual Reports, Investigational Device Exemptions (IDEs), and potentially other regulatory documents, such as Master Drug Files (DMS). The Senior Regulatory Affairs Scientist will ensure that all filings to applicable agencies (e.g. Food and Drug Administration [FDA], National Institutes of Health [NIH] and others) are complete, in compliance with set regulations, accurate, and support acceptance. These regulatory and related materials will be prepared in collaboration and with input from City of Hope researchers and cores for investigational products developed by small to medium companies created by City of Hope- Investigators/Researchers and that are being supported by the Translational Development Center at City of Hope. Due to the diverse nature of projects within this center, the position also requires adaptability to new projects, ability to quickly take on novel investigational products and the regulatory strategy presented with them, and a thorough scientific background in biology.

Key Responsibilities include:
  • The key functions for this position are: 1) understanding regulatory affairs with respect to investigational drug and device review and approval, compliance and commercialization; and 2) scientific writing.
  • This position requires a significant awareness of compliance (Good Laboratory Practices [GLP], Good Manufacturing Practices [GMP], and Good Clinical Practices [GCP]), deadlines, and translational research, including basic research, manufacturing, and clinical trials.
  • Based on data provided by Investigators/Researchers, prepare, write and edit filings that provide applicable, accurate and sufficient information to support acceptance.
  • Serves as primary contact for submission and revisions of regulatory documents either to the Office of IND Development and Regulatory Affairs at City of Hope or to the regulatory partners of study sponsors, upon review by the Translational Development Center Director.
  • Manage several ongoing regulatory projects and submissions at one time; developing timelines for receipt of information, follow-up, due dates and project completion.
  • Performs other related duties as assigned or requested, such as presentation of draft regulatory ideas and plans to investigators, coordination of meetings required to create collaborative interactions both within and outside City of Hope, with the study Sponsors, and reporting of progress to the Principal Investigator, Sponsors and the Translational Development Center.
  • Develop in-depth knowledge of the Translational Development Center goals and areas of emphasis towards achieving the enterprise vision.

Basic education, experience and skills required for consideration:
  • Requires a PhD in biology or other life science with at least one year of experience in Regulatory Affairs, or a Master's degree or a Bachelor's degree with at least three years of relevant writing and Regulatory Affairs experience.
  • Must have at least 3 years of clinical experience
  • Strong written and verbal English; Work collaboratively; Meet deadlines; Attention to details; Perform multiple tasks simultaneously; prioritize; and judgment that could affect image of City of Hope.


Preferred education experience and skills:
  • Three or more years of Regulatory Affairs experience, preferably in a healthcare/research/academic environment.
  • A solid understanding of Regulatory Affairs and submissions of INDs to the FDA
  • Experience with cellular, oncology or immunotherapy investigational products and writing of INDs and related documents is preferred.

City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.

Company

City of Hope, an innovative biomedical research, treatment and educational institution with over 5,000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.

Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research.  City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation’s 20 leading cancer centers that develops and institutes standards of care for cancer treatment.

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