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CMC Specialist

Cork, Ireland

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Req ID R-19573 Title CMC Specialist City Cork State / Province Cork Country Ireland Region Research

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Purpose:

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 Lilly products sourced from the US and/or contributing MSRAs, for both Lilly 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 Lilly 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 Lilly 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)

Problem Solving:

  • 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
  • Consult with department regulatory representatives and country affiliates to share best practices and move towards more efficient and effective business processes.
  • 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

Impact:

  • 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.

Project Management:

  • Oversee and manage activities to register new products and renew existing products in global markets.
  • 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.
  • Manage tracking process for certification documents to ensure delivery and receipt.

Customer/ External Focus

  • Establish and maintain excellent verbal and written communication with contributors and country affiliates, many of whom do not have English as a first language.
  • Develop expertise in a dynamic regulatory environment to monitor and communicate increased global reporting requirements to regulatory representatives.  Enhance oversight of business critical registration activities to favorably impact 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.
  • Work with department regulatory representatives and country affiliates to share best practices and move towards more efficient and effective business processes.
  • Develop expertise in a dynamic regulatory environment to monitor and communicate increased global reporting requirements to regulatory representatives.  Enhance oversight of business critical registration activities to favorably impact product registration timelines.

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
  • Proven ability to take initiative and identify opportunities to contribute to product and prcess 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
  • HS Diploma or equivalent required
  • General required skills also include multi-tasking numerous parallel projects, positive attitude and willingness to explore new solutions

Other Information/Additional Preferences:

Notary Public authorization preferred

Associate’s degree strongly preferred

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-19573.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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