CMC (Chemistry, Manufacturing & Control) Specialist fluent English Full Time Permanent

CMC (Chemistry, Manufacturing & Control) Specialist 

Responsibilities:

• Participate in global submission strategy development, by utilizing internal databases (RRIC) 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.
• 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 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.
• Accountable for interpreting approval information from RAPT and Commitment Confirmation into commitment tracking matrix and accurately identify post-approval commitments for global markets.
• Responsible for first response to global MOH inquires and requests: triaging clarifications  issues that product team support.
• 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)
• Serve as a resource for the expert use of computer applications (i.e., RAPT, RRIC) and templates.
• Responsible for proactively communicating with regulatory representatives regarding intercontinental market information, including interpretation of RAPT information and summaries of regulatory project status
• Lead the effort to manage development of responses to questions from Health Authorities.
• Responsible for proactively communicating with regulatory representatives regarding intercontinental market information, including interpretation of RAPT information and summaries of regulatory project status
• Provide expert advice regarding regulatory documents and regulatory processes relating to registration of new products and renewal of existing products in Emerging Market countries.
• Work with department regulatory representatives and country affiliates to share best practices and move towards more efficient and effective business processes.
• Positively impact regulatory cross-functional initiatives through active participation in process improvement projects, drafting/reviewing RQS documents, and problem solving.
• Responsible for monitoring and reporting metrics for global registration activities (including NCE, renewal, manufacturing and source change activities) and provide regular updates to regulatory representatives and management.
• Proactively influence and negotiate with both internal and external customers to meet critical product registration timelines.
• Plan, track and record all steps of product submission activities using the appropriate computer databases (i.e., RRIC, RAPT, IDD, Regulus) to obtain and record the various document and item requirements needed by the affiliate for the each country’s registration.

Minimum Qualification:

• 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
• HS Diploma or equivalent required
• General required skills also include multi-tasking numerous parallel projects, positive attitude and willingness to explore new solutions