Regulatory Affairs Specialist

Location
Rockville, MD
Posted
Jul 26, 2017
Closes
Aug 03, 2017
Function
Other
Industry
Science
Hours
Full Time

The EMMES Corporation, organized in 1977, is a privately owned Contract Research Organization (CRO) located in Rockville, Maryland. 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. Emmes is seeking a Regulatory Affairs Specialist.

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.

Primary Responsibilities

  • 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
Requirements

  • Possess a working knowledge and understanding of ICH, GCP and relevant regulatory agency requirements domestically and internationally
  • Minimum Bachelor’s degree in a scientific discipline with at least 3 years experience as a Regulatory Associate or Regulatory Manager
  • 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

Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs.

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Emmes is proud to be an Equal Opportunity Employer. EOE/M/F/D/V

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