Advanced Regulatory Affairs Specialist

Description

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.

Qualifications

Education and Experience: 

• Bachelor's degree with 3-5 years of relevant experience in regulatory affairs in an IVD manufacturing environment; Or, a master’s degree with up to 2 years of relevant experience

Knowledge, Skills, and Abilities: 

• Excellent attention to detail and organizational skills are required.
• Demonstrated success working on a cross-functional team.
• Working knowledge of Microsoft Word and Excel are required.
• Computer entry, typing, or electronic document filing skills are required. 
• Results-driven with demonstrated ability to find solutions and achieve company goals in an effective, efficient manner.
• Able to flourish in a fast-paced, multi-tasking dynamic environment.
• Able to build strong relationships across a wide spectrum of internal and external parties.
• Ability to prioritize personal work to meet deadlines and complete multiple tasks accurately and efficiently in a fast-paced environment.
• Must have excellent verbal and written communication skills. 
• Demonstrate knowledge of product lines.

Why Join Bio-Techne:

• We offer competitive salaries along with extensive medical, vision, and dental plans for you and your family starting on day one!
• We invest in our employees’ financial futures through 401k matching and an employee stock purchase plan.
• We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more.
• We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging. 
• We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Bio-Techne is an E-Verify Employer in the United States.