Regulatory Specialist

6 month contract to permanent 

Onsite in Bethesda - Hybrid schedule

RESPONSIBIILTES

• Prepare Investigational New Drug Applications (INDs) and lifecycle submissions including Annual
• Reports, Safety Reports, Responses to FDA Requests for Information, etc.
• Prepares other Scientific and Regulatory documents for submission to Regulatory Authorities including pre-IND Meeting Requests and Packages, Orphan Drug Designation requests, Priority Review requests, Fast Track requests, etc.
• Performs regulatory reviews of clinical research protocols
• Performs literature searches, attends meetings, etc. as needed to support regulatory document preparation, regulatory intelligence, and regulatory strategy, and to stay current with applicable therapeutic areas of clients.
• Prepares meeting minutes for clients and provides project management, technical, and logistical support for projects as needed.
• Effectively engage in high-profile communications and interactions with colleagues, collaborators, clients, regulatory health authority staff, and pharma staff as appropriate.
• Develop and maintain work process tools to promote efficiency and productivity. These may include templates, SOPs, work instructions, checklists, trackers, etc.
• Track regulatory activity, maintain and update databases, and ensure that records are complete, accurate, and current

REQUIREMENTS

• Ph.D. or M.S. or equivalent with related experience in pharmacology, toxicology, Biochemistry, molecular biology, immunology, regulatory affairs, or another applicable field.
• Professional or educational background in a scientific field, clinical trials, regulatory affairs or health care; familiarity with GCP and/or experience working in an FDA-regulated environment is desirable. General knowledge of the drug/vaccine development process or clinical trials is a plus.
• Experience in preparing regulatory documents, publishing regulatory submissions using electronic publishing software and proficiency in preparing documents that are compliant with electronic submission standards is a plus.
• Excellent oral and written communication skills; detail-oriented and able to multi-task.
• Superior organizational skills and customer service abilities.
• Strong working knowledge of Microsoft office; experience with SharePoint a plus.