- 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
- 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.
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Regulatory Specialist - Bethesda, United States - Beacon Hill Life Sciences - Boston
Description
Job Description
Job Description6 month contract to permanent
Onsite in Bethesda - Hybrid schedule
RESPONSIBIILTES
REQUIREMENTS
If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser:
Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.
Company Description
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.\r\r
If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: \r
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Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.
