Regulatory Affairs Specialist

About This Role

This role ensures that Roswell Park's Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications, along with other regulatory submissions, comply with FDA regulations. The specialist advises investigators on FDA requirements for specific applications, including pre-clinical, pharmacological, toxicology, chemistry, manufacturing, and control of investigational agents.

Responsibilities

• Ensure Roswell Park INDs/IDEs and other regulatory submission types 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, pharmacological, toxicology, chemistry, manufacturing, and control of investigational agents
• Interpret and apply FDA regulations to investigational product applications
• Provide regulatory input, advice, and guidance to investigators
• Maintain and track FDA regulatory submissions electronically

Requirements

• Bachelor’s degree and the equivalent of four (4) years of full-time research experience
• Two (2) years of the required experience must have been in regulatory affairs, clinical research, or a related field involving FDA regulations
• Obtain a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) within three (3) years of appointment 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 have:

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

Important Details

• Weekly Hours: 40
• Shift: First Shift
• This is a grant-funded position. Compliance with funding requirements such as time and effort reporting, grant deliverables, and contract deliverables is required.

About the Company

Health Research, Inc. (HRI) Roswell Park Division is committed to providing an environment where patients, families, employees, and community are treated with courtesy and respect. They support an inclusive environment that nurtures the talents, skills, and abilities of each individual to embody and reflect their core values: Innovation, Integrity, Teamwork, Commitment, Compassion, and Respect. HRI Roswell Park Division participates in the E-Verify program.