Global GxP Regulatory Intelligence Compendia Manager
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Job Description
Global GxP Regulatory Intelligence Compendia Manager overseeing ongoing monitoring and management of compendial updates to ensure compliance with regulations. Responsible for reporting and cross-functional collaboration.
Responsibilities:
- Responsible for ongoing monitoring and management of compendial updates for clinical and commercial programs
- Ensure compliance with global pharmacopoeia standards and regulatory submissions
- Analyze changes in compendial requirements
- Provide regular updates to internal stakeholders
- Ensure timely implementation of compendial changes
- Develop and oversee the execution of Corrective and Preventive Actions (CAPAs)
- Maintain accurate and up-to-date records of compendial changes
- Collaborate with cross-functional teams
Requirements:
- A minimum of a bachelor’s degree in science or related discipline
- 5-6 years of experience in GMP pharmaceutical/biopharmaceutical industry
- Understands cGMP concepts and general practices
- Knowledge and experience in Pharmacopeia, Monographs and Standards and associated revisions
- Analytical Background
- Strong attention to detail
- Project Management and Meeting Facilitation Skills
- Veeva CAPA Management
Benefits:
- Medical benefits
- Compensation details provided by third-party agency partner
- Overtime pay eligibility
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