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Regulatory Affairs Specialist

2 months ago

St Joseph, United States Astrix Full time

Senior Specialist Regulatory Affairs

  • Hybrid work schedule: required to be in the office 2-3 days per week
  • $35.00 per hour
  • Anywhere between 8 am to 5 pm
  • Monday-Friday as scheduled and aligned with manager.
  • Location can be St. Joseph, MO or Athens, GA


Job Description:

  • Independently perform computerized system testing and proactively suggest improvements in systems and processes.
  • Ensure that all submissions are prepared per established requirements and submitted within established timelines.
  • Maintain working knowledge of regulations, policies, and guidelines with appropriate agencies.
  • Assist in preparing regulatory submissions for activities.
  • Maintains advanced and current knowledge of relevant regulations, policies, and guidelines and acts as Regulatory Affairs Subject Matter Expert in assigned areas.
  • Understand and monitor regulatory trends; understand and implement regulations and guidance.

Education:

  • Bachelor's degree, preferably in science, and 3 years relevant industry experience

Skills

  • Strong proficiency in supporting computerized system migration, testing, and implementation of new systems and system enhancements.
  • Strong experience creating detailed work instructions, training materials and communications.
  • Experience in organizing and facilitating cross-functional meetings and trainings.
  • Regulatory Affairs or equivalent industry experience is required - Intrapreneurial spirit while being rigorous and disciplined with compliance requirements.
  • Self-motivated with a high degree of initiative, commitment and persistence.