Position Summary:

Nusano is seeking a dynamic and highly skilled Vice President of Regulatory Affairs & Quality Assurance to lead and oversee the regulatory and quality assurance functions at Nusano's state of-the-art facility in West Valley City, Utah. This role requires deep industry knowledge and expertise in radiopharmaceuticals, as it plays a pivotal role in shaping the future of cancer care.

Reporting directly to the Chief Operating Officer, the Vice President of Regulatory Affairs & Quality Assurance will provide strategic direction and operational leadership to the Environmental Health & Safety and Quality Assurance departments. This is a unique
opportunity to drive groundbreaking advancements in radioisotope production and make a significant impact on the fight against cancer.

Responsibilities:

Regulatory Strategy and Compliance:

• Develop and execute a comprehensive regulatory strategy to ensure compliance with all
  relevant national and international regulations, standards, and guidelines governing
  radioisotope production.
• Establish and maintain relationships with regulatory agencies, actively participating in
  interactions and submissions to secure necessary approvals and licenses.
• Monitor and stay informed about evolving regulatory requirements, proactively adapting
  Nusano's processes and procedures to maintain compliance.
• Ensure the timely completion of all regulatory licenses required for the operation and
  delivery of our radioisotopes to customers.
• Analyze product specification requirements from our target customers and actively
  support the development initiatives to meet these specific needs.
• Collaborate with the cross-functional team to optimize Nusano's performance and
  enhance our ability to meet our customer's needs.

Quality Assurance Leadership:

• Provide oversight of the Quality Assurance department, ensuring that quality
  management systems are robust, effective, and in alignment with industry best practices.
• Lead efforts to establish and maintain a culture of quality excellence throughout the
  organization, with a focus on continuous improvement and risk mitigation.
• Manage the development and implementation of quality control procedures, including
  supplier quality management, to uphold the integrity of Nusano's products.

Environmental Health & Safety:

• Collaborate with the Director of Environmental Health & Safety to design and execute
  safety programs that promote a culture of safety, risk prevention, and compliance with
  environmental regulations.
• Ensure that Nusano's operations adhere to the highest standards of safety, occupational
  health, and environmental protection.

Supply Chain and Vendor Management:

• Oversee the assessment and qualification of suppliers and partners to guarantee the
  reliability and quality of raw materials used in radioisotope production.
• Develop and maintain strong relationships with key suppliers and ensure their adherence
  to Nusano's quality and regulatory standards.

Auditing and Inspection Readiness:

• Prepare the organization for regulatory inspections and customer audits, ensuring that all
  necessary documentation, procedures, and personnel are in compliance.
• Lead the development and execution of robust internal audit programs to identify and
  address compliance gaps.

Risk Management:

• Identify and evaluate potential quality and regulatory risks and develop risk mitigation
  plans to proactively address issues that may impact the supply of radioisotopes.
• Foster a culture of risk awareness and effective risk management throughout the
  organization.

Requirements:

• A Bachelor's degree in a relevant scientific field is required; advanced degrees such as a
  Master's or Ph.D. in a related discipline is highly desirable.
• A minimum of 15 years of experience in regulatory affairs and quality assurance, with a
  strong emphasis on the radiopharmaceutical industry.
• In-depth knowledge of national and international regulatory frameworks and standards
  relevant to radioisotope production.
• Demonstrated success in managing regulatory approvals and compliance for radioisotope
  products.
• Proven experience in leading quality assurance and quality control programs, including
  cGMP standards.
• Strong leadership skills with the ability to motivate and manage teams effectively.
• Exceptional communication and interpersonal skills, with the ability to collaborate and
  build relationships with regulatory agencies and industry partners.
• Exceptional problem-solving and decision-making capabilities in complex, highly
  regulated environments.
• Highly organized with excellent project management skills.

About Nusano:

No patient should be denied the cancer care they need simply because some options are in short supply or unavailable. Yet, all too often, this is what happens.

Nusano is a medical technology company that creates radioisotopes used to target and eliminate cancer cells with precision. Health care has used radioisotopes to diagnose and treat cancer and other diseases for decades. But, if supply does not keep up with demand, patients will lose out on the benefits of these lifesaving, proven tools.

Nusanos patented technologies and methods are poised to transform radioisotope production and usher in an exciting new era in cancer care. Our state-of-the-art facility in West Valley City, Utah will produce radioisotopes quickly, efficiently, and affordably. This will make desperately needed resources available to hospitals and cancer clinics around the world and offer those with life-threatening diseases hope for a healthier tomorrow.

• Comprehensive medical, dental, and vision coverage for employees and their eligible dependents
• Stock Options
• 401(K) Retirement Plan
• Company-paid life insurance & AD&D coverage
• Company-paid short-term disability coverage
• Healthcare Flexible Spending Account (FSA)
• Dependent Care Reimbursement Account (DCRA)
• Voluntary Life Insurance
• Employee Assistance Program (EAP)
• Vacation, Sick Time, and Holidays