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Purcelloleary Recruitment are looking to recruit a CMC Specialist (Chemistry, Maufacturing, Control) for a pharmaceutical company in Co. Cork. This is initially a REMOTE position; however, the successful candidate will be required on site when the company re-opens the building.
- Lead the effort to draft initial CMC Tracking Tool documents for newly transferred products through interpretation of initial dossiers, Q&A from Health Authorities, and other agency communications to identify CMC commitments. Responsible for monitoring and reporting metrics for global registration activities via RAPT (including NCE, renewal, manufacturing and source change activities) and provide regular updates to regulatory representatives and management.
- Coordinate global registration activities and provide the necessary documentation to affiliates for registration of products in global countries. Duties include preparing and/or expertise in requesting Indiana Free Sale Certificates, FDA Certificates of Pharmaceutical Product (CPPs), MOH GMP Certificates, Price Certificates, Regulatory Status Letters, and Letters of Clarification.
- Demonstrate in-depth understanding of content requirements, including awareness and understanding of CTD format, internal compliance to full versus core dossier content and apply expertise to ensure global regulatory commitment tracking
- Responsible for preparing updates to CMC CTD content consistent with approved manufacturing changes and procedural requirements.
- Coordinate activities to appropriately archive electronic documentation
- Utilize IDD to distribute CMC content globally.
- Knowledge of CMC regulatory requirements
- Prepares CMC documents for global regulatory submissions from approved technical content, leveraging existing tools and processes
- Oversee and manage activities to register new products and renew existing products in global markets.
- Demonstrated knowledge of post-approval Chemistry, Manufacturing and Control (CMC) processes, including CMC Planning and Tracking Tools.
- Proficiency in the use of RRIC for the assessment of global requirements
- Expert user of RAPT for global planning and tracking of submission activity
- Knowledge and understanding of ICH requirements regarding CTD formatting
- Proficiency in eCTDXpress
- Strong computer skills with proficiency in MS applications including MS Word, and Excel
- Proficiency in SharePoint technology
If you would like to discuss this position, please reach out to Louise Whitty on 083 4296073 / email@example.com