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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

CMC Regulatory Specialist


Reference:SCAKLW-773037 Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

CMC Regulatory Specialist
Our client, a global pharma company are currently recruiting for a CMC Regulatory Specialist to join their team on a permanent basis.As CMC Regulatory Specialist you will support new product approvals, existing product renewals, and post-approval changes for global registrations, through document distribution and internal database maintenance. You will closely with regulatory product representatives providing guidance to them regarding the regulatory documentation, reporting requirements and registration processes in global markets. As CMC Regulatory Specialist you will provide leadership and business process knowledge to customers along with organization skills and prioritization ability to identify, initiate and maintain global product CMC commitments the organisations global products.

Responsibilities:

  • Participate in global submission strategy development, by utilizing internal databases and external assessments, in order to identify country specific requirements; identification of submission bundling opportunities via use of the CMC Planning Tool; apply expertise to influence strategies to enable successful global approval with minimal supply chain impact
  • 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
  • Maintain and update the affidavits for each drug product
  • 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
  • Responsible for communicating and adhering to document coding requirements, revision management, and documenting ‘reasons for revision’ to facilitate accurate record keeping
  • Coordinate activities to appropriately archive electronic documentation
  • Verify invoices and prepare disbursement vouchers for payment of courier service and FDA charges.
  • Reconcile department accounts to maintain adequate funds for legalization/consularization fees and ensure integrity of such disbursements to US and foreign government agencies
  • 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
Requirements
  • Bachelor’s Degree in a scientific or health sciences discipline (e.g. pharmacy, chemistry or related scientific discipline)
  • 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
  • Proven ability to take initiative and identify opportunities to contribute to product and process improvements
  • Self-motivated individual with demonstrated ability to identify issues and solutions for a positive result
  • Demonstrated analytical thinking and problem solving skills
  • Proven strong written and verbal communication skills
  • Demonstrated capability to track numerous communications and ensure timely response and completion of deliverable
  • Flexibility – able to handle time pressures
  • Ability to prioritize workload and organize accordingly
  • Effective interpersonal skills; can work as part of a team