HRI offers a competitive salary and comprehensive benefits package.
Description of Duties:
The Regulatory Affairs Specialist 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.
Applicants must possess a Bachelor’s degree and the equivalent of four years of full-time research experience, two years which must have been in regulatory affairs, clinical research or a related field involving FDA regulations. Also, a current certification by the Regulatory Affairs Professionals Society (RAPS) preferred; or ability to secure RAC within three years of employment. The preferred candidate will have experience in preparing and submitting FDA regulatory applications, astrong working knowledge of FDA regulations pertaining to drugs, biologics, devices and tobacco products and an advanced proficiency in Microsoft Office Suite (Word, Excel, Outlook, etc.), Adobe Acrobat, and other electronic platforms needed to prepare electronic submissions (i.e., eCTD). The preferred candidate will also have the ability to prioritize, multi-task, and organize; the ability to be detail oriented and self-directed; the ability to perform duties and problem solve with minimal supervision; the ability to work collaboratively and establish and maintain interpersonal relationships in a manner which enhances communication and problem resolution and possess strong verbal and written communication skills.
This is a grant-funded position. Compliance with funding requirements such as time and effort reporting, grant deliverables, and contract deliverables is required.
Health Research Incorporated (HRI) Roswell Park Division participates in the E-Verify program.
Affirmative Action/Equal Opportunity Employer/Qualified Individuals with Disabilities/Qualified Protected Veterans
Applicants must reference the Posting # when applying for this position.
Interested applicants may apply by uploading a cover letter and resume below in Microsoft Word or PDF format.