Senior Regulatory Compliance Specialist
hace 7 días
About the Role
Parexel is seeking a highly motivated and detail-oriented Senior Regulatory Compliance Specialist to join our team. 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 compliance activities, including research on regulatory updates, communication to stakeholders, and tracking the impact and implementation actions.
- Act as the point person for regulatory consultancy services.
- Assist the Parexel Quality group in the preparation for and follow-up of internal/external audits and inspections.
- 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.
- Generate metrics on regulatory compliance activities.
Requirements
- Educated to degree level (technology, biological science, pharmacy, or other health-related discipline preferred).
- 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.
- Project management capabilities applicable to regulatory compliance activities.
- Excellent interpersonal, verbal, and written communication skills.
- Ability to rapidly learn, understand, and apply corporate procedures.
Salary Range
$80,000 - $120,000 per annum, depending on experience.
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