Lilly Pharma Regulatory Affairs Job For Pharma & Chemistry, Apply Online
CMC Specialist (GRA) – Regulatory Affairs
Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full Time, Regular
Job Id: R-72983
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 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 (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. This includes:
- New product submissions
- Product renewal submissions
- Post-approval changes
- Single and multi-product manufacturing site registrations renewals
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 relevant country Affiliate representatives and other stakeholders such as CMC Reg Associates, Regulatory Scientists, and manufacturing sites including Indianapolis, Fegersheim, Sesto, Kinsale, other Lilly sites, CMOs, and TPOs.The Regulatory CMC Associate/Specialist is expected to provide business process knowledge and regulatory subject matter expertise to all stakeholders.
Primary Responsibilities:
This job description provides a general overview of the job requirements. Job responsibilities may change over time and may include additional responsibilities not specifically described here.
1. Functional and Technical Expertise:
- Contribute to the global submission strategy by developing and utilizing information management expertise and country-specific knowledge to support regulatory documentation for all CMC elements of CTD Module 1 and regional information.
- Coordinate global registration activities and request/provide necessary documentation to affiliates for product registration in global countries. Duties include preparing or requesting COAs, FDA Certificates of Pharmaceutical Product (CPPs), MOH GMP Certificates, monographs, Regulatory Letters, and Declarations.
- Demonstrate in-depth understanding of content requirements, including awareness and understanding of CTD format (Module 1).
- Prepare updates to CMC CTD content consistent with approved manufacturing changes and procedural requirements primarily for Module 1 support.
- Communicate and adhere to document naming conventions and classification requirements, revision management, and document ‘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 funds for legalization/consularization fees and ensure integrity of disbursements to U.S. 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 (Document Finalization Test) activities for assigned products.
2. Decision Making:
- Monitor and track the CMC Submission mailbox and take timely action on assigned projects.
- Prioritize submissions based on due dates and ensure work is completed on time.
- Progress submission support work proactively for other Lilly sites and sponsored CMOs.
3. Influence:
- Create and leverage key relationships internally and externally to influence document processing through government bureaucracies.
- Influence and negotiate with internal and external customers to meet critical product registration timelines.
- Act as liaison between various Indiana and U.S. government agencies (e.g., Indiana Dept. of Health, Indiana Secretary of State, FDA, Dept. of State) and foreign consulates to ensure timely processing of legal approvals.
- Consult with department regulatory representatives and country affiliates to share best practices and improve business processes.
- Provide system and process training to internal employees and serve as department representative to project/process improvement teams.
4. Problem Solving:
- Proactively communicate with regulatory representatives regarding intercontinental market information, including interpretation and project status summaries.
- Share best practices with department regulatory representatives and country affiliates to improve efficiency and effectiveness.
- Contribute to developing responses to Health Authorities’ questions.
5. Impact:
- Provide expert advice on regulatory documents and processes for registering new and renewing existing products in Emerging Market countries.
- Positively impact regulatory cross-functional initiatives by participating in process improvement projects, drafting/reviewing RQS documents, and problem-solving.
- Monitor and report metrics for global registration activities, providing updates to regulatory representatives and management.
6. Project Management:
- Manage activities to register new products and renew existing products in global markets.
- Plan, track, and record product submission activities, using appropriate systems to document requirements needed by affiliates for registration.
- Manage the certification tracking process to ensure delivery and receipt.
7. Customer/External Focus:
- Establish and maintain excellent communication with contributors and affiliates, many of whom may not have English as a first language.
- Develop expertise in a dynamic regulatory environment to communicate global reporting requirements to regulatory representatives.
- Act as a liaison between U.S. and foreign government agencies to ensure timely processing of approvals.
- Monitor and communicate increased global reporting requirements and share best practices with regulatory representatives and affiliates.
Minimum Qualification Requirements:
- Degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related field) or equivalent work experience.
- Proficiency in using Regulatory Information management systems for assessing global requirements and tracking submission activity.
- Knowledge and understanding of ICH requirements regarding CTD formatting.
Other Information/Additional Preferences:
- Strong computer skills with proficiency in MS applications (MS Word, Excel).
- Proficiency in SharePoint technology.
- Ability to take initiative and identify opportunities for product and process improvements.
- Self-motivated with demonstrated ability to identify issues and solutions for positive results.
- Analytical thinking and problem-solving skills.
- Strong written and verbal communication skills.
- Ability to manage multiple communications and ensure timely responses and deliverable completion.
- Flexibility to meet compressed timelines associated with submission deadlines.
- Effective interpersonal skills and ability to work as part of a team.
Link to Apply: APPLY ONLINE HERE
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