Regulatory Affairs Specialist

Location: Pittsburgh
Reports to: Regulatory Arraird & Quality VP
Manages Others:  No
Education: Bachelor’s or Masters Degree in a scientific discipline
Related Degree Programs: Biology, Chemistry, Microbiology, Biochemistry
Work Experience Requirement:  10+ years with Bachelor’s, 8+ years with Master’s in an FDA regulated industry, 2+ years of regulatory affairs experience
A combination of experience and/or education will be taken into consideration

ABOUT NOVEOME BIOTHERAPEUTICS, INC.

Noveome Biotherapeutics, Inc.is a clinical stage biopharmaceutical company with an innovative platform technology that represents a paradigm shift in the development of novel therapeutics. Unlike most drugs that are single molecules/single targets, Noveome’s product is a complex mixture of biomolecules that has the ability to address a wide range of conditions and injuries. Noveome collaborates with major research centers to advance these therapeutic applications.

Position Objective:

The Regulatory Affairs Specialistis responsible for providing regulatory oversight on submissions to health authorities in order to support all phases of human clinical trials and commercialization of a novel biopharmaceutical product.  This position represents the regulatory function on cross functional teams to support drug development activities as necessary.  The Regulatory Affairs Specialist authors regulatory submissions and provides oversight and review to enable timely, high quality submissions to the applicable regulatory agencies

What you will do for Noveome:
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

Please note, as a company rooted in innovation, our positions are consistently evolving and we champion the development of all roles. This job description is not designed to contain comprehensive listing of all responsibilities that are required, as they may change to meet the ongoing needs of the Company.

Required qualifications:

Beneficial qualifications:

Attributes of success:

Work environment/physical demands

Subject to extended periods of sitting and/or standing, vision to monitor and typing. Work is generally performed in a temperature controlled office environment.

Regular schedule

This is an exempt, full time position with a regular schedule of Monday through Friday work hours.  After an initial training period is complete a later start time may be needed to avoid conflicting equipment usage needs.  Extended hours may be needed on occasion to complete company objectives.

What Noveome will do for you

Noveome provides transparency in expectations, encourages innovative thinking, opportunities for expanded learning, competitive salaries, and a clean safe work environment.  Eligible employees will appreciate the comprehensive benefits package and wellness perks.  Best of all you will enjoy working with colleagues at all levels in our open receptive work environment.

For consideration, please send your CV and cover letter to careers@noveome.com.

Noveome, Inc. is committed to a policy of equal opportunity for all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, marital status, citizenship status, sexual orientation, disability, genetic predisposition or carrier status, military or veteran status or any other protected characteristic in accordance with applicable federal, state and local law.


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