The Regulatory Affairs Analyst will be responsible for providing regulatory expertise for activities pertaining to the development of FDA-regulated products. Duties may include coordinating and executing program evaluations for various efforts, interpreting and summarizing qualitative and numerical data to provide useful information, ensuring compliance for various FDA, DoD, and other government regulations and policies.
Develop project plans for yearly assessment of acquisition programs on average of up to fifteen performers’ covering an estimated five to seven medical acquisition programs.
Preparation, drafting, and coordination annual and routine programmatic data calls and necessary acquisition and programmatic documentation.
Provide regulatory expertise and advisement in the preclinical and clinical research and other activities for the development of U.S. Food and Drug Administration (FDA) regulated products (e.g., drug, biologics, devices) to include advisement/review on FDA correspondence, clinical protocol review, and evaluation, IND / IDE applications, the full spectrum of regulatory documentation, regulatory strategies.
Prepare, create, and coordinate project and programmatic memorandums in compliance with appropriate program classification guides and other acquisition guidelines to support the program.
Plan, organize, document, and execute technical programmatic reviews.
Provide comprehensive archive management, including compilation, retention, logging, indexing, retrieval, and storage of correspondence, presentation, and financial files including briefings, quarterly and final reports, technical papers, and other documents for each project.
Other duties, as assigned
Minimum Education and Experience
Bachelor’s degree, in biomedical or associated sciences
Ten years of relevant work experience
Two years experience in Regulatory Affairs and product development through discovery to U.S. Food and Drug Administration (FDA) licensure
Regulatory oversight and management experience
Knowledge of the FDA regulatory process for biomedical products
Experience in FDA regulated research, development, test, and evaluation programs
Demonstrated strength in oral and written communication skills and the ability to interact on a professional and technical level with FDA, DoD, academic, industry, and other stakeholders on regulatory matters
Strong computer skills and intermediate Microsoft Office abilities, including the ability to work in SharePoint to accomplish tasks
Highly organized, efficient, and extremely detail-oriented
Ability to prioritize among multiple tasks and organize information in a fast-paced, deadline-driven environment, relying on your own resources and initiative
Skills that Set You Apart
If you don’t have all of the skills below, don’t be discouraged—no resume paints a complete picture of a person. There’s a good chance you’re more wonderful than you think, so please apply!
Masters degree and a minimum of eight years of experience
Professional certifications (e.g. Regulatory Affair Certification (RAC)) or equivalent
Experience in clinical development activities for medical research or related experience preferred with FDA regulated products (e.g., drugs, biologics, devices)
Internal Number: 2021
About Ripple Effect
Ripple Effect provides professional consulting and exceptional talent for federal, private, and non-profit clients to deliver some of the most crucial policies and programs that shape our nation. We are researchers and communicators, scientists, analysts and more, driven by curiosity and a commitment to positively impact health, safety and prosperity.