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Regulatory Affairs Specialist

3 months ago

Saint Joseph, United States Astrix Full time

Our client is a global, research-driven pharmaceutical focusing on treatment options for diseases and conditions for which there is no satisfactory treatment option to date. The company is looking for a Regulatory Affairs Specialist to join the team. This is an amazing opportunity to work on cutting edge treatments and make a difference


Type of Role: 1.5 year contract

Schedule: M-F 8a-5p

Pay: $35/hr



Regulatory Affairs Specialist Key Responsibilities:

  • Independently support data maintenance and archival and retrieval of regulatory documentation in computerized systems.
  • Assist with preparing high quality US regulatory submissions required by local and federal agencies for company products.
  • 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.
  • Contribute to the development and implementation of applicable work processes and instructions.
  • Maintain 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.
  • 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 company products and processes.



Regulatory Affairs Specialist Education/Experience:

  • Associate’s degree and 5 years of relevant experience OR Bachelor’s degree and 3 years of relevant experience
  • Regulatory Affairs experience required