Regulatory Intelligence Expert

3 weeks ago

Bloemfontein, Orange Free State, South Africa Parexel Full time
Regulatory Intelligence Specialist

Parexel is a leading global biopharmaceutical solutions organization that provides a broad range of expertise, including regulatory intelligence, to support the development and delivery of new and existing medicines.

We are seeking a highly motivated and detail-oriented individual to join our team as a Regulatory Intelligence Specialist. This role will be responsible for ensuring that Parexel stays up to date with regulatory updates and implements relevant requirements.

Key Responsibilities:
  • Lead and coordinate all Regulatory Intelligence activities, including research on regulatory updates, communication to stakeholders, and tracking the impact and implementation actions.
  • Act as the point person for regulatory intelligence related consultancy.
  • Assist the Parexel Quality group in the preparation for and follow-up of internal/external audits and inspections, as needed and relevant to Regulatory Intelligence Activities.
  • Maintain the Regulatory Intelligence SharePoint and filing areas.
  • Provide technical knowledge where appropriate.
  • Collaborate with Parexel Quality to develop and update quality/process documents, tools, and templates in line with regulatory intelligence activities.
  • Generate metrics on Regulatory Intelligence Activities.
  • Contribute to the metrics provided to Senior Management.
  • Complete assigned goals for key QMS elements, with a special focus on Knowledge Management/Regulatory intelligence activities and oversight.
  • Undertake other duties as assigned.
Requirements:
  • Educated to degree level (technology, biological science, pharmacy, or other health-related discipline preferred) or equivalent qualification or clinical research experience.
  • Experience in Quality Assurance, Quality Management, Regulatory Affairs, Clinical Research, Monitoring, Data Management, Pharmacy, Laboratory, or other relevant areas.
  • Good understanding of regulatory affairs landscape.
  • Experience working with clinical trials.
  • Project management capabilities applicable to Regulatory Intelligence activities and oversight.
  • Excellent interpersonal, verbal, and written communication skills, including the ability to present at meetings and training sessions.
  • Ability to rapidly learn, understand, and apply applicable corporate procedures.
  • Excellent time management skills, with the ability to prioritize workload and manage multiple tasks/projects with enthusiasm.
  • Ability to lead projects and teams.
  • Strong ability to analyze and interpret data.
  • Attention to detail and advanced organizational skills.
  • IT literate, with a strong ability to work with Microsoft-based applications and relevant Regulatory Intelligence applications.
  • Proficiency in written and oral English.

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