Regulatory Affairs Specialist III

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Regulatory Affairs Specialist

US Remote Worker

The Emmes Company, LLC ("Emmes) is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

The Regulatory Affairs Specialist is responsible for coordinating the regulatory aspects of multiple projects, investigational products, and study phases, and works with the project teams to provide support regarding 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.

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, informed consent documents, 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
  • Provides guidance for and participates as necessary in submissions to Institutional Review Boards/Ethics Committees
  • Establishes timelines for the drafting, review and 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 and external stakeholders.
  • Provides guidance and applicable documentation for transfer of Sponsor regulatory obligations to Emmes
  • 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
  • Participates 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), corporate SOP development, and project work instructions 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 SOPs
  • Maintains documentation required by corporate and project SOPs

Experience
  • 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
  • 2 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
  • Can 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, including across multiple projects and subject areas
  • Have strong skills in MS Word, Excel, and Outlook
  • Experience working both on HHS-funded and Industry funded clinical studies is a plus


Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
  • Unlimited Approved Leave
  • Tuition Reimbursement
  • 401k & Profit Sharing Plan
  • Work From Home Anywhere in the US
  • Maternal/Paternal Leave
  • Casual Dress Code/Work Environment

CONNECT WITH US!

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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.

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