What are the responsibilities and job description for the FDA Regulatory Affairs Specialist position at Hoskinson Biotechnology?
About:
Hoskinson Health & Wellness Clinic is a leading-edge healthcare institution with a strong commitment to innovation in anti-aging and regenerative medicine. We are rapidly expanding our research and development capabilities, with a focus on creating FDA-approved products that address emerging trends in healthcare. Stem cell research is a cornerstone of our efforts, and we aim to bring cutting-edge, commercially viable solutions to market that redefine patient care and outcomes.
In addition to clinical care, we are deeply engaged in clinical research, with a dedicated team focused on understanding the 12 causes of aging. Their discoveries help us to shape healthcare solutions that could maintain and improve your health as you age. We are in the process of building a state-of-the-art research lab aimed at developing FDA-approved products and advancing evidence-based medicine.
Job Summary:
We are seeking an FDA Regulatory Affairs Specialist with extensive experience in product development, particularly in regulatory processes and commercialization in the area of stem cell research and regenerative medicine. This role is pivotal in bridging the gap between science, FDA and commercialization, ensuring the success of groundbreaking products in the healthcare market. They will ensure compliance with regulatory requirements, scientific excellence, and market-readiness.
Key Responsibilities:
Product Development Leadership:
Collaborate with the science & product development divisions to focus their efforts, streamline project timelines, and ensure steady progress.
Interface with research operations and leadership to align product development with organizational goals and market demands.
Bring forward innovative, cutting-edge product ideas and provide detailed feasibility analyses, including cost, time, and resource requirements.
Communicate with leadership on progress and ensure it maintains at a steady rate to keep development on track.
Obtain clinical sites to gather the appropriate number of patients to reach statistical significance.
Stem Cell Product Development:
Leverage proven experience with stem cell therapies or related FDA-approved products for development initiatives.
Translate scientific advancements in stem cells into viable commercial products that align with the organization’s vision for anti-aging and regenerative medicine.
Provide insights into emerging trends and opportunities in the field of cell therapy.
Collaborate with manufacturing and regulatory teams to ensure that products meet the required safety, efficacy, and quality standards.
Regulatory and Compliance Expertise:
Navigate the FDA approval process, ensuring compliance with all regulatory requirements.
Provide strategic guidance on the design and implementation of FDA trials, including timelines, resource allocation, and patient recruitment.
Establish and maintain relationships with both internal and external clinical sites to support trials as they progress to larger patient cohorts.
Offer insights into trial complexity, including statistical requirements and necessary resources to achieve FDA approval.
Be part of preparation and submission of necessary regulatory filings, clinical trial applications, and documentation.
Stay up-to-date with the evolving regulatory landscape for stem cell and regenerative medicine products.
Team Collaboration and Innovation:
Interface with the science & research teams to transform abstract ideas into focused, actionable projects.
Encourage creativity and forward-thinking while maintaining a pragmatic approach to development timelines and budgets.
Market and Commercial Strategy
Conduct market analyses to assess sales potential, ROI, and economic impact of proposed products.
Develop comprehensive product plans, including pricing, launch strategies, and market positioning.
Partner with marketing and sales teams to ensure successful product launches and sustained market adoption.
Collaboration and External Partnerships:
Cultivate strategic partnerships with universities, hospitals, research organizations, and other biotech firms to leverage additional resources and expertise.
Engage with external experts, including clinical trial centers, regulatory bodies, and industry partners, to advance the development and commercialization of stem cell-based products.
Represent the company at industry conferences and scientific meetings, promoting the company’s stem cell research and product portfolio.
Communication and Reporting:
Communicate complex scientific and regulatory information related to product development clearly to both technical and non-technical stakeholders.
All other duties as assigned.
Education/Certifications/Licenses
Advanced degree in a relevant field (e.g., biomedical engineering, pharmacology, or life sciences). MBA preferred.
Experience
Minimum 10 years of experience in product development within the healthcare industry, including a proven track record of launching FDA-approved products.
Specific expertise in stem cell research and development, with a history of successfully navigating FDA processes for stem cell-based products.
Extensive experience navigating the regulatory processes for stem cell and regenerative medicine products, including FDA, EMA, and ICH guidelines.
Proven success in the commercialization of cell-based products, including successful regulatory approvals and market launch.
Familiarity with intellectual property management, patent filing, and protection of stem cell-based innovations.
Required Skills/Abilities
Have a passion to produce cutting edge products based on new evolving trends in the antiaging and regenerative medicine field.
Strong understanding of anti-aging and regenerative medicine trends.
Exceptional leadership skills with a demonstrated ability to manage complex multidisciplinary complex and keep them on track.
Financial acumen, including experience with cost analysis, ROI projections, and budgeting.
Proven ability to collaborate with external clinical sites for patient recruitment and trial management.
Outstanding communication and problem-solving skills, with the ability to present complex concepts to diverse stakeholders.
Strong project management skills with the ability to prioritize and manage multiple initiatives.
Excellent verbal and written communication skills, particularly in conveying complex scientific information to diverse audiences
Why Join Us?
- Work in a pioneering organization that combines cutting-edge science with a commitment to redefining patient care.
- Be at the forefront of stem cell research and regenerative medicine, bringing transformative products to market.
- Collaborate with a multidisciplinary team of innovators in a supportive, family-owned environment.
- Enjoy access to state-of-the-art facilities and the opportunity to make a significant impact in a rapidly growing institution.
Benefits:
- Health Insurance: The company covers 100% of health insurance premiums, including medical, dental, vision, short term disability, long term disability, and Life Insurance coverage.
- Supplemental Insurance: Employees have voluntary access to additional policies such as hospital, cancer coverage, accident insurance, and voluntary life through a supplemental provider.
- Retirement Benefits: Enjoy a generous retirement plan with a competitive company match - no waiting period required.
- Paid Time Off (PTO): Benefit from a generous PTO policy.
- Professional Development: Hoskinson Health and Wellness Clinic supports the professional growth of all employees by offering assistance for continuing or additional education with Human Resources approval.
Company Mission and Philosophy:
Hoskinson Health & Wellness Clinic is owned by physicians who have teamed together to help end discrepancies they have seen for decades in the healthcare space. Our mission is to help patients truly live better, healthier lives by providing comprehensive care through a variety of specialists and support services. To ensure this mission is met, we focus on integrating highly effective technology, encourage collaboration among the team, and take lower patient volumes to allow patients more time with our staff.
This is a unique opportunity to shape the future of regenerative medicine and anti-aging therapies. If you have the expertise and drive to lead transformative innovation, we want to hear from you!
Hoskinson Health & Wellness Clinic is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information. The Clinic is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, contact Human Resources at 307-387-9850.
