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Specializing in FDA Regulatory Matters

FDA Regulated Industry Consultant

Job Purpose/Summary 

Independent Consultants for EAS Consulting Group, LLC work closely and collaboratively with members of the EAS team, our clients, as well as our other independent consultants to provide expert direction and guidance to clients based on the most current and accurate regulatory environment. Consultants are 1099 independent contractors to EAS, their integrity, professionalism and subject matter expertise continue to further enhance EAS’ industry reputation as a premier consulting firm for FDA regulated industries.

Core Responsibilities

  • Provides consulting services to EAS clients based on independent consultant’s commodity expertise. Examples of services may include compliance, remediation, training, quality systems, labeling and claims substantiation, FDA filings and submissions, and regulatory intelligence. Client services are provided based on specific requests and projects.
  • Promotes the vision of EAS in coordination with EAS Senior Management.
  • Maintains the reputation of EAS as an industry leader in regulatory consulting services.
  • May collaborate with EAS Senior Management on business development opportunities.
  • Responsible for independently completing client projects, in a timely manner, based on the scope and deliverables as agreed upon by written contract between EAS Consulting Group and the client.
  • Researches, obtains and communicates regulatory information to EAS clients.
  • Maintain strict client and project confidentiality.

Qualifications

The Independent Consultant will have a college degree in a scientific discipline and a minimum of 10 – 15 years of regulatory and/or strategic management experience in the FDA or FDA regulated industries. Extensive experience working at the FDA, a consulting firms or at a senior management positions within an FDA regulated industry required. Ability to manage complex quality and regulatory projects and issues and excellent leadership and decision-making skills are a must. Must be willing to travel to client sites as requested. Must have the ability to understand, organize and work concurrently on multiple projects, each with specific requirements. Must have excellent written and oral communication skills in order to effectively communicate with both EAS and clients and provide detail written reports and opinions.

Applications

Send Cover Letter and CV to Susan Catloth – scatloth@easconsultinggroup.com

About EAS

EAS Consulting Group, LLC (EAS) specializes in Food and Drug Administration (FDA) regulatory matters. Our prime focus is to assist domestic and foreign pharmaceutical, medical device, tobacco, food, dietary supplement, and cosmetic firms comply with applicable laws and regulations. EAS is staffed with former FDA compliance and inspection officials and industry executives and is assisted by an extensive network of consultants with many years of FDA and industry experience. EAS is headquartered in Alexandria, VA with consultants and auditors located strategically throughout North America, Asia-Pacific, UK and the EU.