- Establish and manage the development and/or review of key documents, including abstracts, presentations, protocols and write reports and regulatory documents for IND, BLA submissions;
- Involvement in preparing pre-IND, Fast Track, Breakthrough or RMAT designation submissions
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Manage activities such as audits and regulatory agency inspections.
- Provide responses to regulatory agencies regarding product information or issues.
- Maintain current knowledge of relevant regulations, including proposed and final rules.
- Maintain regulatory or compliance documentation.
- Examine marketing materials to ensure compliance with policies or regulations.
- Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
- Establish regulatory priorities or budgets and allocate resources and workloads.
- Establish and develop relationships with key opinion leaders
- One of the following combinations of education and experience is required: (A) a minimum of a bachelor’s degree plus 6 years of health regulated industry experience OR (B) a master level degree plus 4 years of health regulated industry experience OR (C) a PharmD/PhD with 2 year health regulated industry.
- A degree in a scientific discipline is preferred
- Strong 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
- Experience responding to FDA requests and managing FDA interactions is required
- Experience lifecycle management of IND/NDA applications is required
- Demonstrated experience in critically reviewing and compiling regulatory documents is required
- Diverse therapeutic area experience is a plus
- A 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
Rion is a clinical-stage biotechnology company based in Rochester, Minnesota. Rion was founded as a Mayo Clinic Employee Entrepreneurial Program startup company. Rion’s mission is to develop clinically impactful and accessible therapies using innovative regenerative medicine technologies based on extracellular vesicle science. Our proprietary exosome platform has the ability to address significant unmet patient needs in many fields of medicine; accordingly, we are actively pursuing clinical programs in wound healing, cardiovascular diseases, and women’s health. Our ultimate mission is to deliver cutting edge solutions accessible to any patient in need, anywhere in the world.
Rion recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue career path their goals, both at work and in their personal lives.
We provide a very competitive compensation package with a unique culture focusing on development and wellbeing of our staff. Below are some of the benefits offered by Rion:
- Full Health, Dental and Vision Insurance for employees and their dependents.
- Health Insurance including PPO or High Deductible Health Plan with Health Savings Account.
- Dental Insurance
- Vision Insurance
- Flexible Spending Accounts (FSA)
- 401k or IRA Retirement Savings
- Life Insurance basic life and supplemental life insurance options for self, spouse, children
- Short and Long-Term Disability Insurance
- Paid Time Off
- Paid Holidays
- Parking benefits
Rion is an equal opportunity employer and 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.
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