Sr. Regulatory Affairs Scientist

Title: Sr. Regulatory Affairs Scientist

Location: Fredrick, MD (Hybrid- two days a week on-site)

The Contractor shall ensure compliance with FDA Sponsor responsibilities, serve as a subject matter expert for regulatory strategy including identifying and mitigating risk, and providing support to integrated project teams and working groups for submissions to and communications with the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health submissions. Regulatory Affairs support includes but is not limited to the following:

-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 on 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 or provide input to 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 for assigned products; review, analyze, and respond to FDA communications and meetings by the regulatory deadline and maintain meeting minutes in EDMS.

-Coordinate, prepare, write, review, obtain, maintain, and archive the required documents for regulatory submissions in EDMS.

• Participate and represent as regulatory subject matter expert in on-site visits at the industry partner manufacturing facility as requested
• Provide regulatory assistance for Quality Management System assessments done at the manufacturing facility performed by ORA or external consultants
• 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
• Enter information in ClinicalTrials.gov for clinical studies prior to study initiation. Provide quality assurance for the data and information entered, and ensure compliance with the current regulatory, DHA, and ORA requirements to include upload of required documents, record verification at least once every 6 months, and updates within 30 days for changes to recruitment status, sponsor IRB, approval etc. Enter clinical study results NLT 12 months after the study's primary completion date.

-Review and provide written critical regulatory feedback on acquisition milestone decision briefings, progress reviews, and other acquisition documents.

-Possess a Regulatory Affairs Certification (RAC)

Must be a US Citizen or full Green Card holder.