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Regulatory Affairs Specialist

2 months ago

St Joseph, United States RootStaff Full time

Job Title: Senior Specialist, US Regulatory Affairs Operations

Location: St, Joseph, MO, 64506 /Athens, GA 30601

Duration: 6 months assignment

Hybrid: 2-3 days onsite

Hourly pay range: $30 to $38/hr. on W2


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. Contribute to the development and implementation of applicable work processes and instructions. Ensure they are kept up to date and implemented.
  • 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. Interact with the authorities in a professional manner. Interfaces with relevant stakeholder groups as needed to ensure compliance. Provide training for team members in assigned areas of responsibility. Provides guidance/direction within the regulatory department and stakeholder groups relative to regulatory compliance of products and processes.
  • With minimum guidance and supervision, support systems for product compliance and maintenance and support key user responsibilities as applicable.
  • Knowledge in relevant Regulatory Affairs areas. Ability to understand and anticipate regulatory trends.
  • Knowledge and established understanding of regulatory legislation and requirements for the maintenance of veterinary products


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.
  • Demonstrated ability to successfully collaborate in a global organization and manage a full workload.
  • Effective communicator with good negotiation and interpersonal skills and the ability to form productive working relationships at all levels across disciplines and nationalities.
  • Strong attention to detail
  • Must exhibit good judgment, and ability to problem-solve issues in daily work
  • Able to meet stringent time and quality demands.
  • Self-motivated with a high degree of initiative, commitment and persistence.
  • Well-developed organizational capabilities.
  • Strong team player who is collaborative with the mission , but able to drive change.
  • AAI Competencies
  • Accountability: Taking ownership for decisions and actions.
  • Agility: Quickly acting with an open mind to face internal and external circumstances. Intrapreneurship: Together with our customers, internal or external, creating innovative ideas to respond to changing needs.


Education:

  • Bachelor's degree, preferably in science, and 3 years relevant industry experience
  • Associate's degree and 5 years of relevant industry experience
  • In lieu of degree, 8 years of relevant industry experience including 3 years related regulatory experience.