Do you have a degree in Chemistry?
If you answered yes to these questions, and you are the kind of person who is interested in professional growth and development, SPL’s Regulatory Affairs team may be the right fit for you!
Scientific Protein Laboratories LLC (SPL) is a biopharmaceutical leader in the development and manufacturing of heparin, pancreatin, heparin derivatives, naturally derived pharmaceuticals, and recombinant proteins from microbial fermentation.
SPL offers a competitive salary, a comprehensive benefits package and a friendly work environment. We have an immediate opening in Waunakee, WI (Madison area) for a Regulatory Affairs Specialist.
This position will provide regulatory support for development and commercial programs. In this role, you will plan, coordinate and oversee regulatory activities. These activities include the preparation of document packages for regulatory submissions, and timely preparation of well-organized and technically accurate submissions to the US FDA and other global agencies. You will also be responsible for preparing and maintaining internal procedures, such as Standard Operating Procedures (SOP), and ensuring regulation compliance.
Working with the Regulatory Affairs leadership, this position helps prepare and maintain submissions to regulatory agencies and required compliance reports. These reports include Drug Master Files (DMFs), as well as Annual Updates and amendments to the DMFs in compliance with ICH Q7 and 21 CFR 210/211.
A B.S. degree in Chemistry, and demonstrated/working knowledge of regulatory affairs, such as 21 CFR 210/211, is required along with at least 2 years of experience in finished dosage form Chemistry Manufacturing Control (CMC). Critical thinking/ problem-solving, writing, oral communication and organizing skills a must. Experience in biologics, bioequivalence and pharmacokinetics is a plus.
SPL offers a competitive salary, a comprehensive benefits package and a friendly work environment.