Regulatory Affairs Intern

Position Summary / Objectives: 

The Regulatory Affairs Intern is an entry-level position that supports the regulatory labeling team in preparing labeling in compliance with applicable regulations, guidance, company procedures and customer requirements; maintaining accurate records and submitting labeling data for review by internal and external stake-holders. Interacts with project teams, customers, and vendors for labeling development and implementation. 

Essential Job Functions: 

· Coordinate with customers, suppliers, and project teams to prepare compliant labeling to support global regulatory submissions, registrations, and filings. Label design, approval, and label implementation. 

· Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents (i.e. FDA, MDR, MDD, ISO, EN, etc.) with respect to labeling and unique identifier requirements.

 · Provide professional customer service to ensure customer requirements are met, communicate regarding pending labeling changes and the status of label implementation. 

· Compile and maintain regulatory documentation databases or systems. · Document and file Regulatory Status Determinations for assessment of labeling. Ensure proper notification and/or approval of labeling changes for impacted jurisdictions. 

· Assist with various special ad hoc projects and other duties as assigned

 Competencies: 

· Determination

 · Integrity 

· Creativity 

· Collaboration 

· Moved by Urgency

 Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing job duties, the employee is occasionally required to stand, walk, sit, use hands to handle or feel objects, tools, or controls, reach with hands and arms, climb stairs, and talk or hear. The employee must occasionally lift or move office products and supplies up to 50 pounds.

 Education, Experience, and Certifications: 

· Progress toward a Bachelor's Degree, Associate’s Degree or equivalent with no experience necessary. 

· Ability to follow written and oral instructions with minimum supervision. 

· Good organizational ability and strong attention to detail. 

· Ability to utilize computer application packages, such as MS Word, Excel, and Adobe. · Good communication skills, both verbal and written. 

Salary Range: $18.00-$22.00 per hour

Regenity Biosciences is an Equal Opportunity Employer. We consider applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status. Regenity Biosciences celebrates the diversity of our team and believes that talent, drive, and experience are the only relevant criteria in evaluating new team members.