Senior Regulatory Compliance Specialist
2 days ago
The SUN PHARMA team is seeking a highly skilled Senior Regulatory Compliance Specialist to support global health authority communications and ensure regulatory compliance across the organization.
As a key member of our team, you will assist the Head of Health Authority Communication and Correspondence in supporting the coordination of regulatory responses, managing quality deliverables, and preparing materials for regulatory meetings.
About the Role- Health Authority Correspondence Management - Assist in reviewing and preparing scientifically accurate, compliant responses to health authority queries and inspection observations. Collaborate with site teams to gather necessary data and draft cohesive, concise responses. Track and manage all regulatory communication activities, ensuring accurate data entry and documentation within regulatory databases in a timely manner.
- Quality Management System Analysis - Assess findings from inspections, audits, and Quality Management Systems to identify areas for global risk mitigation. Provide support to internal teams to develop appropriate corrective actions.
- Inspection Readiness – Provide support for all regulatory audits, internal/external inspections, and other audits. Support mock inspections, including review of documents for compliance to current regulations.
- Compliance Tracking and Reporting - Monitor updates and perform gap assessments on regulatory requirements, especially related to aseptic environments and quality management.
- Degree in a Science/Pharmacy-related field required.
- 10+ years of experience in quality within the pharmaceutical industry, including experience in an aseptic environment. Microbiology experience is desirable.
- Knowledge of GxP, cGMP, Quality Systems, and other regulatory requirements.
- Proficient in Quality Management Systems (QMS) with experience analyzing QMS data.
- Significant experience in global health authority inspections and audits in the pharmaceutical industry, direct involvement as a team member in writing responses. Experience responding to FDA, MHRA, EMA, or WHO is preferred.
Salary: $120,000 - $150,000 per annum, depending on qualifications and experience.
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