Regulatory Affairs Associate
Are you looking to be part of something extraordinary and meaningful that is helping thousands of patients across the country every day? NorthStar Medical Radioisotopes is seeking motivated individuals like you to join our rapidly growing team in Beloit, WI. Innovative technology, Opportunities for career advancement, and competitive compensation are just the beginning at NorthStar. In addition to health and life insurance, paid holidays, and paid time off, all NorthStar employees are eligible on Day One for our annual bonus and equity incentive plans.
NorthStar develops, manufactures and distributes radioisotopes that are used daily for patients needing medically important diagnostic imaging tests. NorthStar is the first company in nearly 30 years to produce the radioisotope Mo-99 in the United States NorthStar’s processes are non-uranium based and the Mo-99 is used by radiopharmacies across the country to produce the imaging radioisotope Tc-99m. NorthStar will scale-up production over the coming months and years and intends to become the industry’s market leader. Beyond Mo-99, we have a pipeline of other novel and medically important isotopes which can further grow our business and provide development opportunities for our employees.
Working with this novel and advanced technology is challenging yet rewarding for talented individuals who want to make a difference and be part of an exciting and rapidly growing business. NorthStar’s people drive our solutions and our success, and we are committed to ensuring that we provide fulfilling work experiences and valuable development opportunities.
The function of a Regulatory Affairs Associate is to combine knowledge of scientific, regulatory and business issues to enable radiopharmaceutical products that are developed, manufactured or distributed to meet required legislation. The individual will support activities within the department and function as a resource within the department. The individual may share knowledge and expertise with others in support of team activities.
Duties and Responsibilities
- Performs report-level publishing and submission-ready activities in accordance with internal standards and regulatory requirements. Write and/or review submission sections and evaluate relative to development strategy and conformance with the regulatory requirements.
- Contribute to multidisciplinary teams with respect to regulatory strategy for drug development including CMC, and commercial requirements through successive stages of development. Apply and advance knowledge of U.S. and international requirements/guidelines applicable to same.
- Provide support for global communications to regulatory authorities by the corporation on all aspects of a product offering: annual updates, responses to requests for information, in accordance with company policies and practices.
- Assist with communication to regulatory authorities and participate in regulatory meetings with regulatory agencies.
- Assist with the regulatory strategy related to CMC for life cycle maintenance of marketed and pre-market product offerings.
- Support NorthStar’s Compliance with State Board of Pharmacy Licensing requirements.
Bachelor’s Degree in pharmacy, biology, chemistry, pharmacology, engineering, or related subject and 1-3 years of experience in the pharmaceutical industry; or equivalent combination of education and experience.
Radiopharmaceutical development, RAC certification, and eCTD submission experience is preferred.
NorthStar Medical Radioisotopes is headquartered in Beloit, Wis. This location is our primary manufacturing site and accommodates all of our corporate functions. Beloit has small city charm, with a lively and renovated downtown, yet is also close to cities such as Madison, Milwaukee, Chicago, and Rockford.
Beloit is a part of the larger South Central Wisconsin/Northern Illinois region, which offers residents and visitors alike a unique blend of urban opportunities and rural, natural beauty. The area, therefore, offers collections of natural, educational, artistic, and historical attractions alongside a wide variety of sporting and social opportunities. There are several cities and many towns within a reasonable commute of Beloit, which offer a wide choice of residential styles and a large number of school district choices for those considering relocation.
If you are interested in applying for this position, please forward your resume to Careers@northstarnm.com with the position title in the subject line.
NorthStar Medical Radioisotopes is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law.
Job posted: 2021-01-07