Regulatory Affairs Specialist jobs in Rochester, MN

Manager Regulatory Affairs

Job details

Job Type: Full-time

Number of hires for this role:1

Qualifications

• Bachelors in Science / Masters (Preferred)
• Regulatory Affairs Experience: Minimum 5 years

Full Job Description

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.

The Regulatory Affairs Manager 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.

Responsibilities:

• Assist in the development, review, and approval of key documents, including abstracts, presentations, protocols for IND and BLA submissions that will meet regulatory requirements
• Prepare simple to intermediate regulatory submissions including Annual Reports, Protocol Amendments, and Information Amendments
• Draft regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards including proper eCTD format.
• Analyze simple to intermediate changes for regulatory impact. Communicate impact to team and complete required documentation for decision.
• Understand and apply regulations, standards, and guidance documents from health authorities related to the design, development, evaluation, or marketing of products.
• Follow regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
• Support activities such as audits and regulatory agency inspections.
• Support responses to regulatory agencies regarding product information or issues.
• Maintain current knowledge of relevant regulations, including proposed and final rules.
• Assess the impact of proposed regulations and guidance documents.

· Maintain regulatory or compliance documentation including communication logs. Identify regulatory compliance problems / recommend solutions

• Participate in product development through involvement in project team meetings.
• Work with clinical research organizations and related partners to assist in the development of clinical research studies and documents that generate data to support market authorizations or promotional materials.

Qualifications:

• One of the following combinations of education and experience is required: (A) a minimum of a bachelor’s degree plus 5 years of health regulated industry experience OR (B) a master level degree plus 4 years of health regulated industry experience.
• A degree in a scientific discipline is preferred
• Basic 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 interacting with FDA is required
• Experience lifecycle management of IND/BLA applications is required
• Demonstrated experience in critically reviewing and compiling regulatory documents is required
• Previous biologic or pharmaceutical Regulatory 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 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.

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Paid time off
• Vision insurance

Work Location:

• Rochester, Minnesota or Remote

Work Remotely:

• Yes, with on-site visit to company Headquarters (Rochester, MN) at maximum twice a month

Job Type: Full-time

Pay: From $113,018.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee stock purchase plan
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid parental leave
• Paid time off
• Retirement plan
• Stock options
• Vision insurance

Experience level:

• 5 years

Schedule:

• Monday to Friday

Ability to Relocate:

• Rochester, MN 55902: Relocate before starting work (Required)

Work Location: Hybrid remote in Rochester, MN 55902