Regulatory Affairs Specialist

Hours Worked: Typically, Monday through Friday, forty-hours per week.

Compensation Range: $20 - $22 an hour (e.g., the job posting is not necessarily reflective of actual compensation that may be earned, and actual compensation is subject to variation due to such factors as locations, education, experience, and skillset).

Position Summary:

The Regulatory Affairs Specialist is responsible for ensuring products meet regulatory standards, prepares and submits applications for approvals, and maintains compliance documentation, while also staying updated on changes in regulations. 

Duties and Responsibilities:

• • Collect and summarize regulatory data from client.
  • Navigate client databases, locating/identifying pertinent information as requested.
  • Ability to interpret information and offer suggestions for moving forward.
  • Prepare detailed summaries of regulatory data and their impact for presentation in weekly client meetings.
  • Compile monthly report of all regulatory updates and client notes made at weekly meetings.
  • Ensure data is compiled and maintained, keeping record of past changes and client decisions on impact.
  • Contribute to development of strategies for streamlining processing and sets processing priorities in accordance with established goals.
  • Communicate effectively, problem solving while performing other essential tasks and responsibilities as assigned.
  • Other duties as assigned.

Skills & Proficiencies:

• Bachelor’s degree in Life Science, Regulatory Affairs, or related area are preferred, but other majors who have taken life science courses will be considered.
• Excellent follow-through to ensure completion of assigned tasks. 
• Ability to work independently in a desk/computer-driven environment.
• Comfortable with repetitive tasks 
• Excellent computer skills- (PowerPoint, Word, troubleshooting)
• Strong attention to detail
• Excellent communication skills – written and verbal.  Ability to summarize information in a concise but relevant manner.
• Strong presentation and note-taking skills.

Education and Experience:

• Bachelor’s Degree required 
• 1+ years of experience working in data review is preferred. Additional experience in customer service is desired.