Quality/Risk Management, US Regulatory Affairs, Worldwide Regulatory Affairs
4 Year Degree
The Emmes Company, LLC is searching for a Regulatory Affairs Specialist located in our Rockville, Maryland or Frederick, Maryland offices. Emmes provides flexibility for office location preference, dependent upon position.
The Emmes Company, LLC is a private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.
Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We provide statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.
The Regulatory Affairs Specialist is responsible for coordinating the regulatory aspects of multiple projects, comprising a variety of investigational products, disease areas, and study phases, and will work with the project teams to provide support regarding the preparation and submission of documentation to regulatory agencies worldwide to ensure clinical trials are conducted according to Federal and International standards, as applicable.
Develops regulatory strategies to advance new drugs, biologics, and combination products through investigational studies and approval processes, including participation in and preparations for pre-IND meetings, the preparation of IND/CTA submissions, and drafting marketing applications (NDA, BLA, etc.)
Participates in development and review of protocols, informed consent documents, investigational plans, Investigator Brochures, nonclinical and clinical data summaries, manufacturing information, and safety monitoring procedures
Reviews regulatory documentation for compliance with applicable regulations, pertinent guidance, including nonclinical reports, Investigator Brochures, Quality (CMC) information, etc.
Prepares, tracks and maintains regulatory submissions, filing amendments and correspondence with the regulatory authorities, including Annual Reports
Provides guidance and participates in submissions to Institutional Review Boards/Ethics Committees
Establishes timelines for the drafting, review and submission of regulatory information. Works with the key contributors and regulatory production team to ensure timely compilation of reports and submissions
Develops and maintains regulatory document templates including those for informed consent/ assent, IND/IDE Annual Reports
Tracks regulatory activities and communicates status to project team and external stakeholders
Provides guidance and applicable documentation for transfer of Sponsor regulatory obligations to Emmes
Provides input to project and functional group teams on regulatory issues regarding clinical trial conduct and the status of regulatory filings
Communicates and collaborates effectively with internal and external clients and colleagues
Participates in project process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT), corporate SOP development, and project work instructions and Compliance/Variance table development, participation of internal and external audits, and professional development activities
Bachelor’s degree in a scientific discipline or equivalent experience
Three years’ experience as a Regulatory Associate or Regulatory Specialist
Working knowledge and understanding of ICH, GCP and relevant regulatory agency requirements domestically and internationally
Direct experience in drafting, filing, and maintaining applications with FDA
Two years of direct experience in processing FDA product submissions and experience in evaluating scientific data and reports preferred
Knowledge of Common Technical Document (CTD) submission format preferred
Must be organized, detail oriented, and have excellent written and oral communication skills
Works independently, functioning within a multidisciplinary team environment
Excellent skills in prioritization, problem solving, organization, decision-making, time management and planning
Ability to prioritize effort across multiple projects and subject areas
Strong skills in MS Word, Excel, and Outlook
MS or PhD in life sciences
Regulatory Affairs Certification (RAC) or equivalent
Experience with HHS- and Industry funded clinical studies
Experience with international submissions and medical devices (domestic and international)
Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs
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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.
Internal Number: 2143
About The Emmes Company, LLC
The EMMES Corporation, organized in 1977, is a privately owned Contract Research Organization (CRO) located in Rockville, Maryland, just outside of Washington, D.C., a short distance from NIH, FDA, and the Route I-270 biotechnology corridor. Emmes is dedicated to providing statistical and epidemiological expertise, computer systems development, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in clinical and biomedical research with a Public Health Impact.