• Do you have a degree in Chemistry?

• Do you have 2 or more years of experience working with CMC sections of pharmaceutical regulations?

• Do you have an interest and passion for Regulatory Affairs?

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!

Company Profile

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.

Position Description

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.

Position Responsibilities
 

• Maintain and assist in the preparation of DMFs for US FDA and Certificates of Suitability for Europe
• Support DMF, IND, and NDA filings by preparing document packages for clients and customer notifications
• Gather data and documentation to generate Annual Updates
• Serve as a Regulatory Affairs back up representative to the Change Control Committee
• Provide support during facility cGMP audits (customer driven and regulatory agencies.
• Other duties/projects as assigned.  Ability to work some extended hours and some weekends, as business needs require.

• Education:  A Bachelor’s Degree in Chemistry or Chemical Engineering is required.
• Preferred experience in areas such as the below:
  • finished dosage form Chemistry, Manufacturing Controls (CMC)
  • cGMP pharmaceutical, laboratory, or manufacturing site
  • personal responsibility investigating and submitting NDAs, DMFs, and CTAs
• Skills: Strong computer and technical writing skills, an enduring attention to detail, and a commitment to appropriately handling confidential material is required.

SPL offers a competitive salary, a comprehensive benefits package and a friendly work environment.