Job Summary/Company:Sparks Group has Partnered with a growing CRO seeking to add new Regulatory Specialists to their team to support new clinical trials. The regulatory Specialist will be responsible for preparing and regulatory documents pertaining to clinical trials. If you are looking to start or continue your career supporting clinical documentation and trials, apply below and call 301-926-7800 for more info!
- 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.
- 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.
- Ph.D. or M.S. or equivalent with related experience in pharmacology, toxicology Biochemistry, molecular biology, immunology, regulatory affairs, or another applicable field.
Qualified candidates should send their resume AND call Sparks Group for additional details. Please note, resume must include a valid email address in order to be considered. We look forward to discussing your background, your current job search, and your potential career path with Sparks Group!
Sparks Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, pregnancy, citizenship, family status, genetic information, disability, or protect veteran status.