Regulatory Affairs Specialist Job Listing at Kelly Services in Gillette, WY (Job ID US3553284_BH9792077)

Description

Regulatory Affairs Specialist
Kelly® Science & Clinical is seeking Regulatory Affairs Specialist for a direct-hire position at a cutting-edge client in Wyoming. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Salary/Pay: $100-130k Depending on experience  
Schedule: Full-Time, Monday – Friday onsite Overview
Our client is an industry-leading healthcare institution at the forefront of anti-aging and regenerative medicine. Their innovation-driven team is committed to transforming clinical care through the development of FDA-approved therapies, with a strong focus on stem cell research and commercialization. The organization is currently expanding its research and development capabilities and launching a state-of-the-art research laboratory dedicated to shaping the future of healthcare.
As a Senior FDA Regulatory Affairs Specialist, you will play a vital leadership role in navigating the complex regulatory environment surrounding the development and commercialization of cell- and stem-cell-based therapies. You will collaborate with internal teams and external partners to ensure FDA compliance and successful product development from concept to market. Responsibilities
Product Development Leadership:

• Guide and streamline product development timelines and deliverables in collaboration with R&D and leadership.
• Evaluate new product concepts, conducting feasibility studies, resource planning, and budget forecasting.
• Communicate development progress and ensure milestone accountability.
• Coordinate patient recruitment strategies and clinical site selection to ensure statistically significant trial design.

Stem Cell Product Development:

• Translate stem cell research into viable, FDA-approvable commercial products.
• Stay ahead of emerging trends in regenerative and cell therapy to drive innovation.
• Ensure collaboration between scientific, manufacturing, and regulatory teams to meet safety and efficacy standards.

Regulatory and Compliance Expertise:

• Lead FDA strategy and submission efforts for INDs, IDEs, and other applicable filings.
• Oversee clinical trial planning, ensuring adherence to FDA, EMA, and ICH guidelines.
• Develop regulatory timelines and identify statistical and operational requirements to achieve approval.
• Collaborate with legal/IP teams to support patent protection and regulatory documentation.
• Interface directly with FDA and other global regulatory authorities as needed.

Cross-functional Team Collaboration:

• Transform abstract scientific concepts into actionable, milestone-driven development projects.
• Foster innovation within budget constraints while maintaining focus on regulatory pathways.

Communication & Reporting:

• Prepare and deliver regulatory updates and scientific presentations to internal and external stakeholders.
• Author and review regulatory documents with clarity and precision.

Qualifications

• Bachelors or Master's degree in a relevant field such as Biomedical Engineering, Pharmacology, or Life Sciences.
• 8–10 years of progressive experience in regulatory affairs, product development, or FDA submission leadership in a healthcare or biotech setting.
• Proven success in achieving FDA approvals for regenerative or stem-cell-based products.
• Extensive experience working under FDA, EMA, and ICH guidelines.
• Expertise in developing and managing clinical trials, including patient recruitment and site management.
• Familiarity with intellectual property strategy related to biological innovations.
• Financial acumen for resource planning, ROI projection, and commercial readiness.
• Exceptional written and verbal communication skills with the ability to present to technical and non-technical audiences.

What happens next:
Once you apply, you'll proceed to next steps if your skills and experience look like a good fit. But don't worry – even if this position doesn't work out, you're still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.




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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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