The Regulatory Affairs Scientist will be located at Fort Detrick in Frederick, Maryland in support of a contract with the Office of Regulated Activities (ORA) under the U.S. Army Medical Research and Development Command (USAMRDC). Though this position is primarily located at the government offices at Fort Detrick, there may be a possibility of remote work due to COVID-19.
ORA is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing medical products for the Warfighter. ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring, and medical and regulatory writing support for FDA-regulated drug, biologic, medical device, and combination products.
The Regulatory Affairs Scientist will ensure compliance with FDA Sponsor responsibilities, serve as a subject matter expert for regulatory strategy, to include identifying and mitigating risk, and provide support to integrated project teams and working groups.
DUTIES AND RESPONSIBILITIES
- Provide subject matter expertise on all regulatory matters related to assigned regulatory projects; ensure leadership and the sponsor’s representative are kept current on the progress of the program through periodic reports
- Provide regulatory support to an integrated product team or working group, which includes working with the team members, advising the team of any FDA-related activities and issues, and attending meetings, updating leadership and the sponsor’s representative through routine reports
- Lead the development of a written regulatory strategy and provide to the Government. The strategy shall describe the regulatory pathway for FDA regulatory approval/licensure/clearance, any possible post-marketing commitments, and shall also describe the target product profile or equivalent that can be used throughout the development process that will describe how a product will be utilized by the end user and provide to the Government.
- Identify and mitigate regulatory risk through a project Risk Register
- Serve as the primary contact with the FDA; review, analyze, and respond to FDA communications and meetings by the regulatory deadline
- Lead the development, organization, and structure of regulatory submissions and meeting minutes in EDMS
- Coordinate, prepare, write, review, obtain, maintain, and archive the required documents for regulatory submissions
- Assist in writing and/or reviewing abstracts, papers, and publications, which shall be written in collaboration with the study team members and submitted to all appropriate approval authorities
- Confirm the need for registration, based on regulation and Army policy, and provide regulatory support for data entry and quality assurance of ClinicalTrials.gov information/entries, a Web-based resource that provides information on publicly and privately supported clinical studies on a wide range of diseases and conditions
- Review and provide written critical regulatory feedback on acquisition milestone decision briefings, progress reviews, and other acquisition documents
- Some travel may be required.
EDUCATION, SKILLS and EXPERIENCE REQUIRED
- Bachelor’s Degree in the sciences.
- 5+ years of regulatory experience: leading the development of writing regulatory strategies for FDA, communicating and responding to the government and FDA on submissions, identifying and mitigating regulatory risk, etc.
- Experience in Federal contracting, government or military/DoD environment preferred.
- Must be highly organized, detail oriented, and perform independently.
- Have excellent Microsoft Excel Spreadsheet skills.
- Excellent written and oral communication skills.
- Must be U.S. citizen and be able to obtain a TI (Public Trust).
Must be a US citizen.
Must be able to pass background and drug testing.
THIS IS A FEDERAL CONTRACT.
About Allied Technologies and Consulting
Allied Technologies and Consulting, LLC is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
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100 Tuscanney Dr., Ste. B2
Frederick, MD 21702.