Regulatory Affairs Specialist: FDA Submissions & Compliance

Roswell Park Comprehensive Cancer Center; Buffalo (NY); On-site; USD 77,000 - 96,000; Full time

Job summary

Health Research, Inc. (HRI) Roswell Park Division is seeking a Regulatory Affairs Specialist to ensure INDs/IDEs and other submissions meet FDA requirements.

You will guide investigators on regulatory expectations across preclinical and clinical development and maintain electronic submission records. The role requires a bachelor’s degree with four years in research (two in regulatory affairs) and RAC ideally within three years.

Qualifications

• Bachelor’s degree and four years of full-time research experience, two in regulatory affairs, with FDA regulations experience.
• Current RAC preferred; or ability to secure RAC within three years of employment.
• Incumbents must obtain RAC within three years of appointment as a condition of continued employment.

Responsibilities

• Ensure Roswell Park INDs/IDEs and other regulatory submissions comply with FDA regulations.
• Keep current on changes in regulations for drugs, biologics, devices and tobacco products.
• Advise investigators on FDA requirements as they apply to specific applications including pre-clinical, pharmacology, toxicology, chemistry, manufacturing and control of investigational agents.
• Interpret and apply FDA regulations to investigational product applications and provide regulatory input and guidance to investigators.
• Maintain and track FDA regulatory submissions electronically.

Skills

FDA regulations knowledge

Regulatory submissions

Document management

Regulatory interpretation

Education

Bachelor’s degree in a related field

Regulatory Affairs Certification (RAC)

Job description

Health Research, Inc. (HRI) Roswell Park Division is seeking a Regulatory Affairs Specialist to ensure INDs/IDEs and other submissions meet FDA requirements.

You will guide investigators on regulatory expectations across preclinical and clinical development and maintain electronic submission records. The role requires a bachelor’s degree with four years in research (two in regulatory affairs) and RAC ideally within three years.