Regulatory Affairs Specialist – Location: Madison, WI to be relocated to Beloit, WI
This position will have primary responsibility to compile, and file DMF and ANDA/NDAs and acquire the appropriate marketing approvals while ensuring compliance with applicable FDA regulations. Secondary responsibilities will be to obtain appropriate international registration with appropriate competent authorities as required by company strategic planning.
The function of a Regulatory Affairs Specialist 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 has department level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide.
We are seeking candidates with a Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, or Engineering and 3-5 years of experience in the pharmaceutical industry, with a minimum of 2 years in regulatory affairs, research and development or quality assurance; or equivalent combination of education and experience.
If you are interested in applying for this position, please forward your resume and salary history to firstname.lastname@example.org with the position title in the subject line.