Regulatory Affairs Specialist

Roswell Park Comprehensive Cancer Center; United States; On-site; USD 77,000 - 96,000; Full time

Job summary

Roswell Park Comprehensive Cancer Center is seeking a Regulatory Affairs Specialist to ensure that INDs/IDEs and other regulatory submissions comply with FDA regulations. You will stay current with changes affecting drugs, biologics, devices and tobacco products and advise investigators on applicable FDA requirements for specific applications.

Interpret regulations, provide regulatory input, guidance to investigators, and maintain FDA submissions electronically, collaborating with the Clinical

Qualifications

• Bachelor’s degree with four years of full-time research experience, two in regulatory affairs.
• Must obtain RAC within three years of employment as a condition of continued employment.
• Degrees from accredited institutions as recognized by Roswell Park.

Responsibilities

• Ensure INDs/IDEs and other regulatory submissions comply with FDA regulations.
• Advise investigators on FDA requirements as they apply to applications.
• Maintain and track FDA regulatory submissions electronically.

Skills

Regulatory affairs

FDA regulations

Education

Bachelor’s degree + 4 years research experience (2 in regulatory affairs)

Regulatory Affairs Certification (RAC) within 3 years

Job description

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)

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.

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.

Qualifications

• 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 belief 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.

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.

Welcome to Roswell Park Comprehensive Cancer Center, America's first cancer center founded in 1898 by Dr. Roswell Park. As one of the largest employers in Western New York, Roswell has over 3,300 employees, including over 200 physicians and scientists and 400 nurses. It’s a new era at Roswell Park. Leading the way in cancer research, treatment and education for more than a century, today Roswell Park is setting our course for a second century of extraordinary advances in cancer research and treatment. Equipped with the best facilities, the sharpest and most creative minds, and the single objective of curing cancer, we stand on the threshold of historic discovery.