Regulatory Affairs Specialist

General Dynamics Information Technology • Fort Detrick, MD

2d • Hybrid

About The Position

GDIT's Military Health team is hiring a Regulatory Affairs Scientist to support the Office of Regulated Activities (ORA) under the DoW (Dept. of Army) located at Ft. Detrick in Frederick, Maryland. The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The 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. The position is located in Frederick, Maryland. It is a hybrid role, and you would be required to be on-site 2 days/week.

Requirements

• Bachelor’s Degree or the equivalent combination of education, professional training, or work experience.
• 5 years of related experience.
• Experience working, submitting and communicating with the FDA is highly preferred.
• Experience developing regulatory strategies for diverse medical products
• Must be highly organized, detail oriented, and perform independently.
• Have excellent Microsoft Excel Spreadsheet skills.
• Excellent written and oral communication skills
• Able to obtain a TI (Public Trust).
• Must be U.S. citizen.

Nice To Haves

• MS in regulatory affairs is preferred.

Responsibilities

• Provide subject matter expertise on all regulatory matters related to assigned regulatory projects; ensure ORA 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 ORA 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.
• Create and maintain Target Product Profiles and provide to the Government. The target product profiles shall contain the indication and usage, dosage and administration, dose forms and strengths, contraindications, warning and precautions, safety adverse reactions and drug interactions, use in specific populations, drug abuse and dependence/overdose, description of drug, clinical/pharmaceutical, pre-clinical toxicology, clinical studies, references, storage and handling, patient counseling, risk evaluation mitigation strategy, and supporting documentation and/or templates as appropriate.
• 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 in EDMS
• 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

Benefits

• 401K with company match
• Professional development, education assistance, certification and training opportunities
• variety of medical plan options, some with Health Savings Accounts
• dental plan options
• a vision plan
• a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match.
• full flex work weeks where possible
• a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave.
• short and long-term disability benefits
• life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level