Regulatory Affairs Specialist
- Full Time
The EMMES Corporation, established in 1977, is a privately-owned Contract Research Organization (CRO). Headquartered in Rockville, Maryland Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, 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 offer statistical 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 the project and works with the project team to provide support with regard to the preparation and submission of documentation to regulatory agencies worldwide requirements and to ensure clinical trials are conducted according to Federal and International standards, as applicable. Regulatory oversight includes monitoring for and contributing to resolution of compliance issues.
Participates in the development of regulatory strategies to advance new drugs, biologics, and devices through the clinical trial and licensure process, including participation in and preparations for pre-IND meetings, the preparation of IND/CTA submissions, and drafting marketing applications (NDA, BLA, 510k, PMA, etc.)
Obtains and reviews for compliance with applicable regulations pertinent information and documentation for regulatory applications from outside sources (e.g., nonclinical reports, Investigator Brochures, Quality information, etc.)
Participates in development and review of protocols, investigational plans, Investigator Brochures, nonclinical and clinical data summaries, manufacturing information, and safety monitoring procedures
Prepares, tracks and maintains regulatory submissions, filing routine amendments and correspondence with the regulatory authorities, including Annual Reports
Establishes timelines for the submission of required information from key individuals for each application, allowing sufficient time to compile information and prepare reports
Works closely within regulatory and with project teams to develop and maintain regulatory document templates including those for informed consent/ assent, IND/IDE Annual Reports, and templates for documents to be collected as part of the Trial Master File (i.e., Financial Disclosure Forms)
Tracks regulatory activities and communicates status to project team.
Tracks regulatory documents for investigational site compliance monitoring as required by project
Reviews and participates in assessment of laboratory and manufacturing activities for GLP/cGMP compliance, assessing and filing required documentation
Reviews and contributes to project-required reports (e.g., contract reports)
Provides oversight and expertise in the establishment of Trial Master Files (TMFs) for studies conducted both domestically and internationally
Participation in regular project team meetings and functional group meetings, providing input on regulatory issues regarding clinical trial conduct and the status of regulatory filings
Communicates and coordinates effectively with internal and external clients and colleagues
Provides recommendations for process improvements
Participates in project process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT), project SOP and Compliance/Variance table development, participation of internal and external audits, and professional development activities
Demonstrates understanding of project and corporate SOPs by producing work in compliance with the SOPs
Maintains documentation required by corporate and project SOPs
Bachelor’s degree in a scientific discipline or equivalent experience; combination of training and experience will be taken under consideration
Possess at least 3 years’ experience as a Regulatory Associate or Regulatory Specialist
Possess a 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 or GMP compliance documents and experience in evaluating scientific data and reports preferred
Regulatory Affairs Certification (RAC) or equivalent preferred
Must be organized, detail oriented, and have excellent written and oral communication skills
Be able to work independently (be self motivated) and within a complex team environment
Excellent skills in prioritization, problem solving, organization, decision-making, time management and planning
Ability to multi-task and prioritize
Have strong skills in MS Word, Excel, and Outlook
Experience working both on HHS-funded and Industry funded clinical studies is a plus
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The EMMES Corporation 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.