Regulatory Affairs Specialist

Title:

Regulatory Affairs Specialist

Job Type:

Regular

Company:

Health Research, Inc. (HRI) Roswell Park Division

Department:

Clinical Trials Office

Time Type:

Full time

Weekly Hours:

40

FTE:

1

Shift:

First Shift (United States of America)

Summary:

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!

Qualifications:

Required Education and Experience

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

Education and Experience
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.

NOTE:
1. 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.
2. 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.

Preferred Qualifications:

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

Equal Employment Opportunity Statement

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.

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

Reasonable Accommodation Request

RPCIC and HRI are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email HR-BenefitsandLeaves@roswellpark.org  and let us know the nature of your request and your contact information.

Our Core Values

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.

Grant Funding

This is a grant-funded position.  Compliance with funding requirements such as time and effort reporting, grant deliverables, and contract deliverables is required.

E-Verify Employer

Health Research Inc. (HRI) Roswell Park Division participates in the E-Verify program.