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About the Role

Ensures that Roswell Park IND’s/IDE’s and other regulatory submission types are in compliance with FDA regulations. Advises investigators on FDA requirements and interprets and applies FDA regulations to investigational product applications. Maintains and tracks FDA regulatory submissions electronically.

Responsibilities

Ensures that Roswell Park IND’s/IDE’s and other regulatory submission types are in compliance with FDA regulations
Keeps current on changes in regulations for drugs, biologics, devices and tobacco products
Advises investigators on FDA requirements as they apply to the specific application which includes pre-clinical, pharmacological, toxicology, chemistry, manufacturing and control of investigational agents
Interprets and applies FDA regulations to investigational product applications and provides regulatory input, advice, guidance to the investigators
Maintains and tracks FDA regulatory submissions electronically
Compliance with funding requirements such as time and effort reporting, grant deliverables, and contract deliverables is required.

Requirements

Current certification by the Regulatory Affairs Professionals Society (RAPS) preferred; or ability to secure RAC within three (3) years of employment.
Bachelor’s degree and the equivalent of four (4) years of full-time research experience, two (2) years which must have been in regulatory affairs, clinical research or a related field involving FDA regulations.
Incumbents must obtain a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) within three (3) years of appointment to this position as a condition of continued employment.
Required degrees must have been granted by an accredited school, college or university or one recognized by Roswell Park Comprehensive Cancer Center as following acceptable educational practices.

Skills

Research Certification
Document management experience
Knowledge of FDA regulations

Location

First Shift (United States of America)

Work Type

Full time

Experience Level

4 years of full-time research experience
2 years in regulatory affairs, clinical research or a related field involving FDA regulations

Education Level

Bachelor’s degree

Salary/Compensations

$77,308- $95,503 annually

Benefits

comprehensive benefits package

About the Company

Health Research, Inc. (HRI) Roswell Park Division
Roswell Park Cancer Institute Corporation (RPCIC) and Health Research Inc. (HRI) Roswell Park Division believe that all persons are entitled to equal employment opportunities, and we do not discriminate against our employees, applicants or job seekers because of their race, color, religion, sex, sexual orientation, gender identity or expression, national origin, creed, age, disability, pregnancy-related condition, military or veteran status, marital or familial status, domestic violence victim status, citizenship status, genetic information, individual’s relationship or association with a member of a protected category or any other protected group status as defined by law.
RPCIC and HRI are committed to providing an environment where patients, families, employees and community are treated with courtesy and respect.
We support an inclusive environment that nurtures the talents, skills and abilities of each individual to embody and reflect our core values: Innovation, Integrity, Teamwork, Commitment, Compassion and Respect.
Health Research Inc. (HRI) Roswell Park Division participates in the E-Verify program.

Equal Opportunity

Affirmative Action/Equal Opportunity Employer/Qualified Individuals with Disabilities/Qualified Protected Veterans