Regulatory Affairs Specialist
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.
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
- Uses knowledge of Food & Drug Administration (FDA) and International Council for Harmonization (ICH) regulations and guidelines to review documents for the development of the Company’s novel drug products.
- Maintains the Investigational New Drug (IND) lifecycle, including drafting all administrative forms and cover letters, publishing of eCTD documents for all electronic transmissions with the health authorities. Maintains tracking of regulatory and quality commitments with submission material documentation.
- Manages the progress of all regulatory submissions including drafting all administrative FDA forms and cover letters, final approval of all electronic submissions with FDA, and record keeping of all submission materials. Assists in drafting responses to FDA comments and interrogatories.
- Prepares IND/Master File submissions, material, amendments, annuals, and safety reports. Reviews Institutional Review Board (IRB) submission documentation for initial approval.
- Point of contact between the Company and eCTD vendors for regulatory submissions. Prepares and publishes final eCTD documents for regulatory agencies.
- Develops Standard Operating Procedures (SOPs) to manage regulatory submissions and obligations. Participates in the creation, review, and finalization of company-wide SOPs and ensures ongoing compliance.
- Supports health authority inspections of both clinical and manufacturing sites. May serve as an escort for health authority inspectors. Participates in inspection close-out meetings and supports written responses to inspection observations.
- Supports the generation of regulatory, clinical, non-clinical, and CMC documentation to health authorities. Reviews clinical protocols, informed consents, investigator brochures, pharmacy manuals, serious adverse event reports, and clinical start-up documents ensuring submission to regulatory authorities.
- Reviews quality and manufacturing changes needed to support change control. Provides support and regulatory strategy for implemented changes.
- Serves as a Regulatory Affairs representative on assigned project teams to provide direction and address regulatory compliance issues.
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.
- Knowledge of FDA, EMA, cGCP, cGMP, cGLP regulations, and ICH guidelines
- Biopharmaceutical drug development
- Regulatory submission management
- Health agency communication
- Microsoft Office Word, Excel, PowerPoint, Adobe, Outlook
- Common Technical Document (CTD) and Electronic CTD format and publishing
- Regulatory submission requirements for drug development including Target Product Profile (TPP)
- Medical Device/combination product experience
- Clinical trial management
- Regulatory Affairs Certification (RAC)
Attributes of success:
- Problem Solving
- Independent Judgement
- Results Oriented
- Time Management
- Interactive Communication
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.
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 firstname.lastname@example.org.
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.