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Purpose:
The CMC (Chemistry, Manufacturing, and Controls) Regulatory CMC Specialist has the primary responsibility to support the completion of Module 1 and any regional information for all submissions where CMC support is required, e.g., new product submissions, product renewal submissions, post-approval changes, single product and multi product manufacturing site registrations renewals etc. This also includes the preparation and appropriate set-up of CMC documents in the Lilly regulatory information management system.
In this role, the CMC Specialist closely monitors and manages the submission work in conjunction with the relevant country Affiliate representative and other relevant stakeholders such as CMC Reg Associates, Regulatory Scientists, and manufacturing sites such as Indianapolis, Fegersheim, Sesto, Kinsale or any additional Lilly sites, CMO’s and TPOs.
The Regulatory CMC Associate/Specialist is expected to provide business process knowledge and regulatory subject matter expertise as appropriate to all stakeholders.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
1. Functional and Technical Expertise:
- Contribute to the global submission strategy, by developing & utilizing appropriate Information management expertise & country specific knowledge to support the regulatory documentation required for all CMC elements of CTD module 1 and any regional information.
- Coordinate global registration activities and request/provide the necessary documentation to affiliates for registration of products in global countries. Duties include preparing/requesting, COAs, FDA Certificates of Pharmaceutical Product (CPPs), MOH GMP Certificates, monographs (US/PhEur) Disclaimers, Regulatory Letters and Declarations.
- Demonstrate in-depth understanding of content requirements, including awareness and understanding of CTD format (module 1),
- Responsible for preparing updates to CMC CTD content consistent with approved manufacturing changes and procedural requirements primarily for module 1 support.
- Responsible for communicating and adhering to document naming convention and classifications requirements, revision management, and documenting ‘reasons for revision’ to facilitate accurate record keeping.
- 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
- Oversee and manage activities to register new products and renew existing products in global markets.
- Provide support for DFT activities (Document finalization Test) for assigned products.
2. Decision Making
- Monitor and track CMC Submission mailbox and take appropriate and timely action on assigned projects.
- Prioritize submissions based on due dates and ensure work is completed according to agreed timelines.
- Proactively progress submission support work for other Lilly sites and Lilly sponsored CMO’s.
3. 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 employees. Serve as department representative to project or process improvement teams.
4. Problem Solving:
- Responsible for proactively communicating with regulatory representatives regarding intercontinental market information, including interpretation of regulatory 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.
- Contribute to the development of responses to questions from Health Authorities.
5. 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.
6. 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 information systems to obtain and record the various document and item requirements needed by the affiliate for each country’s registration.
- Manage tracking process for certification documents to ensure delivery and receipt.
7. 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 favourably 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 favourably impact product registration timelines.
Minimum Qualification Requirements:
- Degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related scientific discipline) or equivalent work experience.
- Proficiency in the use of Regulatory Information management systems for the assessment of global requirements for global planning and tracking of submission activity.
- Knowledge and understanding of ICH requirements regarding CTD formatting.
Other Information/Additional Preferences:
- 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 deliverables.
- Flexibility – ability to cope with compressed timelines associated with certain submission deadlines.
- Ability to prioritize workload and organize accordingly.
- Effective interpersonal skills; can work as part of a team.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.
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