Assoc. Regulatory Affairs Specialist

This position helps prepare and maintain submissions to regulatory agencies and required compliance reports, such as DMF’s and Annual Updates and amendments to DMF’s.

• Keep current with changing EC Drug Substance or Active Pharmaceutical Ingredient (API) registration requirements.
• Keep current with changing FDA cGMP requirements and Code of Federal Regulations application to the DMF’s.
• Prepare document pkgs. for clients in support of DMF, IND and NDA filings.
• Reviews USP/NF Pharmacopoeial Forum Supplements to stay current with upcoming changes in the compendia and alerts QC/QA.

Requirements: Bachelors degree in a Life Sciences field such as chemistry, biology or microbiology. Minimum of 2 yrs. previous experience in a cGMP pharmaceutical and laboratory, mfg. site required. Reg. Affairs experience including ECTD experience preferred. Intermediate level knowledge of Word, Excel, Access and Windows environment. Detail oriented. Good communication skills. Good attendance.

Scientific Protein Laboratories LLC
Attn: Human Resources
700 E. Main St.
Waunakee, WI 53597
Fax: 608-849-1610