Regulatory Affairs Specialist

Health Research, Inc. (HRI) Roswell Park Division operates the Clinical Trials Office at Roswell Park Comprehensive Cancer Center. The Regulatory Affairs Specialist ensures investigational product submissions comply with FDA regulations, advises investigators on regulatory requirements, and maintains electronic tracking of FDA submissions.

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

Preferred

Current certification by the Regulatory Affairs Professionals Society (RAPS) preferred; or ability to secure RAC within three (3) years of employment

The preferred candidate will have, Research Certification, Document management experience and Knowledge of FDA regulations

Current certification by the Regulatory Affairs Professionals Society (RAPS) preferred; or ability to secure RAC within three (3) years of employment.

RAC certification

Research certification

Document management

FDA regulations knowledge

Benefits

A comprehensive benefits package

Company

Comprehensive cancer care, research, education, and innovation center

Buffalo, NY, US

https://www.roswellpark.org/

Founded in 1898

1001-5000 employees

Qualifications

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

Current certification by the Regulatory Affairs Professionals Society (RAPS) preferred; or ability to secure RAC within three (3) years of employment

The preferred candidate will have, Research Certification, Document management experience and Knowledge of FDA regulations

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 skills

FDA Regulations, Regulatory Affairs, Clinical Research, Regulatory Affairs Certification (RAC), Document Management, Research Certification

Experience

4+ years