TITLE: Director, Drug/Device Consulting Services
REPORTS TO: President & COO
Responsible for managing the drug and device consulting activities within EAS Consulting Group, LLC. Functions as regulatory and business leader of the drug and device group and establishes its mission and goals. This responsibility includes close working relationships with members of the EAS team, our drug and device clients, and our consultants. Maintains the quality and consistency of the group’s drug, device, submissions and intelligence service to clients.
- Provides consulting services to clients regarding Drug and Device requirements, FDA filings and submissions, and regulatory intelligence.
- Maintains the vision of EAS in coordination with EAS Senior Management.
- Maintains reputation for EAS as an industry leader in drug and device regulatory consulting, submissions and intelligence.
- Works collaboratively with EAS Senior Management to develop business plan (short & long term) with inclusion of marketing strategies and new business opportunities.
- Develops solutions to a variety of complex problems.
- Accountable for the day to day management of drug and device regulatory consulting services, submissions and intelligence activities
- Acts as point of contact for new and current drug and device clients, regulatory authorities and senior managers within the EAS organization.
- Prepares proposals for drug and device clients
- Identifies and assigns appropriate EAS staff to client projects based on their regulatory, technical and industry knowledge.
- Oversees submissions to the U.S. FDA including but not limited to:
- DMFs, VMFs INDs, ANDAs, NDAs, 510(k)s, Suitability Petition, Controlled Correspondence
- Familiar with GDUFA, FDA U.S. Agent and User Fees
- Oversees Freedom of Information requests on behalf of clients
- Researches, locates, identifies and obtains information from FDA’s Dockets Management Branch Office.
- Manages the submission of SPL files including:
- Labeler Code Requests, Establishment Registrations, Products Listings, GDUFA Self-Identification
The Candidate must have a college degree with a minimum of 10 – 15 years of combined pharmaceutical and/or device and regulatory management related experience. Candidate should also have strong experience in Regulatory Affairs for FDA regulated products. Prior industry experience working closely
with the FDA, in a consulting firm or in a senior management position in the US FDA is desired. Strong regulatory management experience in a complex matrix environment is strongly desired. Excellent leadership and decision making skills are required. Must have the ability to understand, organize and supervise staff to work concurrently on multiple projects, each with specific requirements.
Send Cover Letter and CV to Dean Cirotta, President and COO at email@example.com
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.