Regulatory Affairs Specialist
Vyriad is a clinical stage biotechnology company focused on curing cancer using potent, safe and cost effective cancer therapies utilizing engineered replication competent viruses designed to selectively and rapidly destroy cancer. Revolutionizing cancer treatment is our long-term goal, requiring curiosity, perseverance, an openness to challenging convention and a commitment to excellence. The challenges are complex, the work pace is fast, and progress is seldom a straight line. All of this makes for an exhilarating environment of collaboration, discovery and fun.
The Regulatory Affairs Specialist is responsible for obtaining and maintaining government approval for investigational drug products and Vyriad sponsored clinical trials. Typically, The Regulatory Specialist individuals activities include document preparation, information management, file maintenance, and coordination of tasks across multiple departments. Part of their strategic directive is to achieve a balance between regulatory concerns, technology, and compliance. The Regulatory Affairs Specialist works in a dynamic work environment where communication with employees at all levels within the organization is extremely important.
- Ensure consistency, completeness and adherence to standards of regulatory submissions.
- Maintain up-to-date knowledge on international and domestic regulatory requirements.
- Perform lifecycle management of existing investigational products, including regulatory impact assessments and strategy development for supplemental applications.
- Monitor the progress of regulatory submissions, responding to queries and ensuring that registration approvals are granted without undue delay.
- Monitor and interpret regulations to evaluate the impact on the business.
- Manage process for case analytics and implements new methodologies to identify patterns and trends concerning important regulatory topics
- Coordinate with product development and/or research and development teams to request, develop, and prepare required data and reports to be submitted to regulatory bodies and agencies.
- Establish and maintain business relationships with officials in federal and state government regulatory agencies.
- Educate staff on regulations, policies, or procedures.
- Performs tasks as assign by leadership staff.
- Identifies potential improvements and leads process improvement teams as needed.
- Facilitates the documentation, design and implementation of new and changed processes.
- Assists with the application of quality management tools for measuring improvements.
- Continually expands knowledge of quality management and regulatory principles.
- Serves as a resource and mentor in quality principles and regulatory requirements.
- Provides continuous and timely performance feedback to direct reports, including coaching on performance management and professional advancement.
- Provides employee recognitions for accomplishments in a thoughtful and timely manner.
- Delegates work assignments to staff as appropriate, considering employee strengths and expertise to address associated tasks.
- Mentors individuals, based on individual needs, to meet current job expectations and career goals.
- Leads the investigation of events that appear to be associated with regulatory violations. Works with relevant parties to resolve issue and take appropriate corrective and preventive action.
Education and Experience:
A bachelor’s degree in a science related field is required and a minimum of 5 years’ experience in a regulatory affairs role in an FDA regulated environment is required or an advanced degree (Ph.D. and/or graduate degree) in a science related field with 3+ years of related work experience.
- Knowledge and experience in FDA Good Manufacturing Practices is highly desirable.
- Exceptional human relations and communication (written, verbal, and listening) skills are required. Should be very detail-oriented with the ability to work independently and productively with minimal direction, and routinely exercise initiative and sound judgment.
- Strong analytic skills coupled with critical thinking skills are essential in this role. Must have demonstrated capacity to comprehend complex protocols, programs, and situations. The ability to exercise good judgment while under pressure and tight deadlines, and strong coping skills are required. Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities.
Monday-Friday 8:00 – 5:00
Rochester, MN (Required)
Work visa sponsorship is not available for this position.
Compensation and benefits:
Salary is commensurate with experience and qualifications. A comprehensive benefits package including:
How to apply
To apply please send a resume and cover letter to firstname.lastname@example.org. References will be requested and background checks will be required prior to start of employment. Applications will be reviewed as received until the position is filled.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Vyriad is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.