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.
What You'll Do:
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)
What Makes a Successful Rippler?
This job description is not intended to be an exhaustive list of all duties, responsibilities, and skills required to be successful in the role. Other duties may be assigned to help make our clients successful and achieve our company goals. We have designed the introductory period to convey company core values and clear expectations of your role.
You pay attention to the details. Anything worth doing is worth doing right, every single time. So you stay organized, meet commitments and deadlines, work efficiently, and always check your work.
You communicate clearly. You consider your audience and take care to get your points across professionally and concisely, both in writing and when speaking to others. You’re comfortable interacting with clients, coworkers, and stakeholders, and respect everyone’s perspective.
You work independently. You know how to manage competing deadlines on multiple simultaneous projects, and can adapt when you need to re-prioritize. When you’re stuck, you take initiative to find resources, and you’re comfortable asking for help when you need it.
You’re eager to learn. You have a track record of learning new things, especially programs, technology, and processes. You embrace change, and if you can’t find a teacher, you teach yourself. Once you learn something new, you are excited to evaluate it and teach it to others.
Ripple Effect works with federal, private, and non-profit clients to support some of the most crucial policies and programs that shape our nation. We provide professional consulting services in the areas of ?Communications & Outreach;?Program Management & Policy; and?Research & Evaluation. Ripple Effect is an interdisciplinary environment, full of insightful and intentional people who value and reward adaptability, lifelong learning, and authenticity. To learn more about working at Ripple Effect and our growing team, check out the?Careers?section of our website.
Our employees are rewarded in many ways for their contributions to our mission, including competitive pay, exceptional benefits, and a range of work/life programs based on employment classification. Benefit offerings may include:
Health Benefits – Health, Dental, and Vision
Life, long-term disability, and other insurance products
Health and Wellness Programs
Flexible Spending and Health Savings Accounts
Retirement 401K program
Profit-sharing and bonus program
Paid and unpaid leave
Flexible schedules and work location
Vetting and Hiring Process
It is the policy of Ripple Effect that:
qualified applicants will receive consideration for employment without regard to race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity, or any other reason prohibited by law in the provision of employment opportunities and benefits;
employment eligibility will be verified using E-verify;
applicants may be asked to participate in assessments during the interview process as described in our Informed Consent Policy; and
applicants will not be reimbursed for any expenses associated with the interview process or relocation.
Internal Number: 0
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.