Regulatory Affairs Manager - Nusano

Position Summary:

At Nusano, we are working to empower the world’s leading companies, health care providers, and innovators with the radioisotopes needed to advance 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.

Nusano is seeking a Regulatory Affairs Manager with extensive experience in developing and filing regulatory submissions. The individual will ensure that the regulatory submissions support the high likelihood of agency approval with minimum regulatory review cycles as well as support a sound regulatory and business risk management strategy. The position is responsible for advocating regulatory concepts and concerns in a practical way throughout the organization, ensuring congruence of technical and scientific goals with regulatory compliance requirements, developing and maintaining a practical set of policies and procedures, coaching and training staff to current regulatory approaches, advising senior leadership, and fostering an integrated understanding of regulatory concerns within all activities.

What You'll Do:

• Provides regulatory affairs insight to Nusano’s leadership and program/project teams.
• Defines and manages regulatory filing strategies for new products and programs based on intended commercialization, which includes identifying optimal scientific and technical paths and regulatory filing routes (e.g. submission through radiopharmaceutical IND/NDA vs DMF for medical uses).
• Participates in risk management reviews through product life cycle and change management internal processes, such as documentation change control and engineering change control.
• Ensures phase-appropriate information scope to support product developer drug development programs.
• Manages regulatory communications with 3rd party drug product developer representatives within defined confidentiality policies and business strategic requirements.
• Manages communication with regulatory agencies, such as managing on site (FDA HQ) and/or virtual meetings and representing the company as required.
• Provides authorship and/or review resources and/or oversight of Common Technical Documents (CTDs), specifically for Drug Master Files (DMFs).
• Manages regulatory contractors selected to perform specific functions on behalf of Nusano (e.g. eCTD Publishing), including 3rd party acting as Nusano’s US Agent when deemed necessary.
• Creates and manages regulatory and training programs for Nusano staff to support compliance with relevant regulations.
• Provides oversight of all labeling material as defined by applicable regulations (NRC, DOT, FDA).
• Ensures compliance with the regulatory terms of the DMF as established under the FDA clearance.
• Supports regulatory compliance of manufacturing sites with relevant regulations, encompassing Nusano’s facilities, Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), and Contract Laboratories.
• Manage junior regulatory staff as needed, including career development, periodic performance reviews, training, and work priority development and assignment.

Minimum Requirements:

• B.S. degree in a life sciences related field, such as chemistry or biology.
• Minimum of 7+ years of experience in the pharmaceutical industry, including development and FDA submission of DMF and/or drug filings (IND, NDA, BLA).
• Direct experience with eCTD development, including managing 3rd party workflow.
• Experience with regulatory risk management in the pre-commercial space (i.e. clinical stage)
• Experience with regulatory review cycles, including managing responses to FDA/EMEA for DMF and/or drug regulatory submissions.
• Experience with various development teams, such as Engineering, Product Development, Technical Operations, Validations.
• Experience working with the Quality Unit towards effective compliance with regulations and effective change management processes.
• Proficient with office software; familiar with regulatory publishing processes.
• Strong verbal and written communication skills.

Preferred Requirements:

• Experience with site inspections performed by regulatory agencies (primarily FDA).
• Experience with the development of radiopharmaceuticals or isotopes.
• Awareness of accelerator (cyclotron, LINAC) processes.
• Familiarity with DOT, NRC, DOE and other regulatory agency requirements.
• Familiarity with radiopharmaceutical development, injectable drug products, and European regulations.
• Direct interface with FDA via multiple modes (face to face, T-con, and emails).
• Familiar with export/import activities relevant to isotopes.
• Prior history of successful regulatory clearance/approval.
• Familiarity with site registration, product listing, and regulatory fees
• Regulatory Affairs certification.

Physical Requirements:

• Work to be conducted in an office environment, laboratories, engineering R&D, and/or production environment.
• Must be comfortable working within radiation environments and/or GMP.
• Must be able to sit for long periods of time.
• Frequent use of computer with repetitive use of keyboard, mouse, and manual dexterity.
• Ability to travel domestically and internationally up to15% of the time.

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.

Nusano’s 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