By joining the Bio-Techne team, you will have an impact on future cutting-edge research. Bio-Techne andall ofits brands provides tools for researchers in Life Sciences and Clinical Diagnostics. 

 

Position Summary: 

The Advanced Regulatory Affairs Specialist provides independent support to senior regulatory staff to submit regulatory filings.  This position will demonstrate advanced knowledge of regulatory changes and assist with communication to customers and regulatory authorities. In this position, you will work closely with internal colleagues and external partners to bring innovative products to market and support our business goals. 

 

Key Responsibilities: 

Compile, analyze and draft reports, SOPs and regulatory filings as assigned.  Communicate effectively across groups and site.  Schedule and guide regulatory and cross-functional team meetings.  Provide input into regulatory functions and protocols.  Good understanding of regulatory body of knowledge and processes.  Draft and revise regulatory filings with little input. Propose and implement process improvements.   Identify changes impacting regulatory submissions.  Research the history of a product as applicable to regulatory submissions.  Consistently demonstrate knowledge of regulatory requirements in daily work.  Utilizes technical systems and relevant internal databases effectively. Assist with regulatory responses and interactions required by regulatory authorities. Support customer questions and for regulatory support.  Collaborates on projects of low to moderate complexity.  Participates in regulatory-related employee training.  Follows company policies and practices, understand appropriate lab protocols and follow standard operating procedures (SOPs) including regulatory awareness of chemical handling and hazards, compliance, and proper use of equipment.  Performs additional duties as assigned.