Job Description

The CMC Regulatory Specialist has the responsibility to support new product approvals, existing product renewals, and post-approval changes for global registrations, through document distribution and internal database maintenance. This includes supporting the registrations of our client’s products sourced from the US and/or contributing MSRAs, for both our client and contract manufacturing sites, to the global marketing affiliates. In this role, the Specialist works closely with Indianapolis regulatory product representatives providing guidance to them regarding the regulatory documentation, reporting requirements and registration processes in global markets. In addition, the Specialist maintains post-approval commitments for products supported from ISRA for both our client and contract manufacturing sites. In this role, the Specialist works closely with Indianapolis regulatory product representatives providing essential CMC commitment information and approval status in global markets as part of manufacturing change control evaluation/completion. The Specialist appropriately updates impacted regulatory documents as part of the change control process. Key customers include the ISRA Regulatory representatives, Indianapolis manufacturing sites and the CMC Regional Centers. The Regulatory Specialist is expected to provide leadership and business process knowledge to these customers along with organization skills and prioritization ability to identify, initiate and maintain global product CMC commitments for our client marketed products.

Key Responsibilities:

Functional and Technical Expertise:

• Participate in global submission strategy development, by utilizing internal databases (RRIC) and external assessements, 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.
• Use of Regulus for document management.
• Understand and communicate global implications to users of Regulus when assessing and requesting changes to document types and system metadata.
• Coordinate activities to appropriately archive electronic documentation
• Utilize IDD to distribute CMC content globally.
• 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.

Decision Making

• Accountable for interpreting approval information from RAPT and Commitment Confirmation into commitment tracking matrix and accurately identify post-approval commitments for global markets.
• Respnonsible for first response to global MOH inquires and requests: triaging clarifications verus issues that product team support.

Influence:

• Create and leverage key relationships internally and externally. Influence through established professional relationships is key to moving documents through government bureaucracies.
• Proactively influence and negotiate with both internal and external customers to meet critical product registration timelines.
• Act as liaison between various Indiana and US government agencies (e.g., Indiana Dept. of Health, Indiana Secretary of State, US Food and Drug Administration, US Dept. of State) and a variety of foreign government consulates to ensure all legal approvals are properly processed and completed in the pre-determined timeframe.
• Consult with department regulatory representatives and country affiliates to share best practices and move towards more efficient and effective business processes.
• Provide system and process training to internal assistants and representatives (e.g. Regulus, Planning and Tracking).
• Serve as department representative to project or process improvement teams (e.g. six sigma or MSRA/Regional Center initiative)

Minimum Qualification Requirements:

• 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