Regulatory Intelligence Specialist

at  Parexel

ABOUT THIS ROLE

We are seeking a highly motivated and detail-oriented Regulatory Intelligence Specialist to join our team. As a Regulatory Intelligence Specialist , you will be responsible for Regulatory Intelligence activities, ensuring that Parexel stays up to date with regulatory updates and implements relevant requirements. You will collaborate closely with stakeholders, contribute to continuous improvement of our Quality Management System (QMS), and play a crucial role in maintaining our compliance standards.

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.

SKILLS AND EXPERIENCE REQUIRED FOR THE ROLE:

• 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 such as Cortellis or Tarius
• Proficiency in written and oral English.