Careers
Come work with RION in the heart of downtown Rochester, a vibrant rapidly-growing city located in Southeast Minnesota.
Located in the home of the number one hospital in the country, time and again, Rochester, MN, ranks among the best places to live in the United States owing to its affordable cost of living, healthy lifestyle, stellar school systems, and exceptional quality of life. Rochester is also well known as a global destination for health and wellness.
For the past decade, state officials in collaboration with the Mayo Clinic and City of Rochester, have implemented Destination Medical Center, a 20-year, $5.6 billion economic development initiative focused on developing Rochester as a global epicenter for life sciences and healthcare innovation. Utilizing public and private investments, Rochester is creating an inviting ecosystem for biotechnology start-up ventures looking to capitalize on a skilled and educated workforce.
MISSION AND VISION
Re-Imagining Medicine
We seek to change the approach to regenerative medicine by utilizing exosome technology to improve the lives of more patients, in more places, across more diseases, from every walk of life.
2017
Year Founded
40+
Number of employees
2
Decades of Research
20
Peer Reviewed Publications
Do you have PEP?
If you are Passionate, Experienced, and Persistent, then RION would be a great fit for you!
RION is assembling a team of top talent from across the country and throughout the pharma/biotech industry. We strongly believe in hiring for culture add, not culture fit. Our lead clinical candidate, PEP™, is core to our mission, but PEP means something different to everyone.
Explore our available positions below by clicking the (+) sign and learn more about our current openings. If one of the available roles is right for you, click the Apply Now and be redirected to the posting.
Available Positions
Veterinary Director/Senior Director Regulatory Affairs
Position Description
The Director/Senior Director of Veterinary Regulatory Affairs will be responsible for overseeing the preparation and submission of regulatory applications, reports, and correspondence related to veterinary products, animal health drugs, and agricultural medicines, specifically within the scope of the FDA’s Center for Veterinary Medicine (CVM). This position will work closely with the FDA-CVM and other regulatory bodies to ensure full compliance with FDA standards for veterinary drugs and animal health products. The role will report directly to the Chief Regulatory Officer.
Requirements:
- Doctor of Veterinary Medicine (DVM) with at least 5 years of experience in regulatory affairs within the animal health industry, or a Master’s degree in veterinary science or a related field with at least 10 years of regulatory experience, or a PharmD/PhD with at least 7 years of experience in veterinary regulatory affairs.
- In-depth knowledge of the drug development and regulatory submission processes within the FDA-CVM framework is required.
- Expertise in FDA-CVM regulations and guidelines concerning veterinary drug development, animal health products, and agricultural medicines.
- Experience managing Investigational New Animal Drug (INAD) applications, New Animal Drug Applications (NADA), and Biologic License Applications (BLA) for veterinary drugs in compliance with FDA-CVM.
- Proven experience preparing INAD applications for clinical trials and studies related to veterinary drugs and animal health products under FDA-CVM.
- Demonstrated ability to manage interactions with FDA-CVM, responding to regulatory inquiries and ensuring compliance throughout the lifecycle of veterinary products.
- Strong experience in lifecycle regulatory management, from submission to ongoing compliance, for veterinary drugs and animal health products.
- Proven ability to critically review and prepare regulatory documents for clinical trials, product development, and labeling for veterinary drugs.
- Strong collaborative skills, with a successful track record of leading regulatory initiatives in the development and approval of veterinary products within FDA-CVM processes.
- Excellent organizational skills and the ability to effectively prioritize multiple regulatory projects, meeting timelines and ensuring high-quality deliverables.
- Exceptional interpersonal, communication, and leadership skills, with the ability to liaise effectively with FDA-CVM, cross-functional teams, and industry stakeholders.
- Strong interpersonal and communication skills
All resumes can be sent to careers@riontx.com
Senior Manager Regulatory Affairs
Position Description
The Sr. Manager Regulatory Affairs will prepare and submit regulatory agency applications, reports, or correspondence with minimal oversight and will report to the Sr. Director of Regulatory Affairs at Rion.
Requirements:
- One of the following combinations of education and experience is required: (A) a minimum of a bachelor’s degree plus 10 years of health regulated industry experience OR (B) a master level degree plus 8 years of health regulated industry experience.
- A degree in a scientific discipline is preferred
- Knowledge of the drug development process and regulatory submission and approval process is required
- Understanding of FDA and ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required
- Previous biologic or pharmaceutical regulatory experience is required
- Experience responding to FDA requests and interacting with FDA is required
- Experience with filing and lifecycle management of IND/BLA applications is required
- Experience with FDA expedited programs is preferred
- Experience in aesthetics is preferred. Experience in dermatology or advanced wound care is a plus.
- Demonstrated experience in critically reviewing and compiling regulatory documents is required
- Proven ability to work successfully within a reciprocal team environment as an individual contributor and decision maker within a cross-functional organization is required
- The ability to effectively prioritize assignments for multiple products and projects simultaneously is required
- Strong interpersonal and communication skills
All resumes can be sent to careers@riontx.com
Sr. Clinical Operations Manager
Position Description
Reporting to the Vice President, Global Clinical Development & Operations, this role manages multiple clinical studies from Protocol Concept and Development to Clinical Study Reporting and Disclosure. This is an exciting opportunity for an individual with an MD background, proven track record of clinical protocol development, managing studies, internal cross-functional collaboration and coordination, CRO and vendor management to join a dynamic team working to deliver high quality studies on time and within budget. The role is key to ensuring that study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data are acceptable and suitable for regulatory submission. This individual ensures that assigned studies are executed according to ICH/GCP guidelines, applicable regulatory requirements and standard operating procedures.
Requirements:
- MD degree from the US or abroad (Medical residency not required and currently not practicing medicine.
- Minimum 10–15 years of experience in the pharmaceutical industry in a senior manager position performing clinical development and operations functions.
- Proven track record including internal cross-functional coordination, CRO and vendor management to deliver high quality studies to time and budget.
- Previous pharma industry experience managing early through late phase studies.
- Demonstrated experience in the identification of emerging risks and the ability to collaboratively champion solutions within a multi-disciplinary drug development team to help resolve challenges.
- Must possess excellent project planning and priority setting skills, as well as excellent organizational and interpersonal skills and flexibility to accommodate rapidly changing priorities and deadlines.
- Solid project and vendor management, analytical and problem-solving skills.
- Prior experience with forecasting, tracking and reconciliation of study budgets.
- Prior experience with authoring and coordinating the development of clinical protocols, Investigator brochures and study reports.
- Excellent written and verbal communication skills.
All resumes can be sent to khan@riontx.com
Don’t see your dream job?
Don’t see a role that fits? No problem! Send us your resume and a note about your dream role for future consideration. We’ll reach out when we have something that fits!
Our Perks
- Health Insurance
- Dental Insurance
- Vision Insurance
- Flexible Spending Accounts (FSA)
- 401K or IRA Retirement Savings
- Supplemental Life Insurance
- Short and Long-Term Disability
- Insurance Paid Family Leave Paid
- Time Off Paid Holidays
- Parking Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Flexible Spending Accounts (FSA)
- 401K or IRA Retirement Savings
- Supplemental Life Insurance
- Short and Long-Term Disability
- Insurance Paid Family Leave Paid
- Time Off Paid Holidays
- Parking Benefits
EEO STATEMENT
RION is proud to be an equal opportunity employer that complies with all applicable federal, state and local fair employment practices laws. RION strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.
RECRUITMENT & STAFFING AGENCIES
RION does not accept agency resumes unless contacted directly by internal RION Talent Acquisition. Please do not forward resumes to RION employees, or any other company locations; RION is not responsible for any fees related to unsolicited resumes.