Regulatory Affairs Specialist

Roswell Park Comprehensive Cancer Center

21h•$77,308 - $95,503•Onsite

About The Position

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. The pay range for this position is $77,308- $95,503 annually which includes a comprehensive benefits package. The listed pay range reflects the range of potential compensation for this role. The actual offer may vary based on qualifications, skills, and experience. We are recruiting for multiple candidates on this posting!

Requirements

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.

Nice To Haves

Current certification by the Regulatory Affairs Professionals Society (RAPS) preferred
Ability to secure RAC within three (3) years of employment.
Research Certification
Document management experience
Knowledge of FDA regulations.

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
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.