The CMC Specialist (GRA) – Regulatory Affairs role at Lilly in Bangalore is ideal for candidates interested in the regulatory aspects of Chemistry, Manufacturing, and Controls (CMC) for global pharmaceutical products. Below is an overview of the role and tips to help you position yourself effectively for this opportunity.

Role Overview

As a CMC Regulatory Specialist, your primary responsibilities include supporting CMC submissions (new product registrations, renewals, post-approval changes) by preparing, organizing, and managing Module 1 and other regulatory documentation. You’ll coordinate with various global stakeholders, including Lilly’s affiliates, Regulatory Scientists, and Manufacturing sites, to ensure all submissions meet regulatory standards and timelines.

Key Responsibilities

1. Regulatory Document Preparation:
   • Support the development of Module 1 of CTD and regional documentation, managing updates and changes based on manufacturing and regulatory requirements.
   • Work on global registration documents such as Certificates of Analysis (COAs), FDA CPPs, GMP Certificates, and Regulatory Declarations.
2. Quality and Compliance Assurance:
   • Ensure CMC documentation adheres to regulatory requirements (FDA, EMA, ICH, GCP), managing document classifications, naming conventions, and accurate record-keeping.
3. Project Management and Coordination:
   • Oversee global product registrations and renewals, maintain communication with regulatory representatives, and ensure all submission activities are recorded and tracked.
4. Collaboration and Communication:
   • Act as a liaison with U.S. and foreign regulatory agencies and consulates, supporting product registration timelines and documentation workflows.

Skills and Qualifications

• Education: Bachelor’s degree in a scientific discipline (e.g., pharmacy, chemistry).
• Experience: Familiarity with global regulatory systems (e.g., CTD formatting, ICH guidelines) and proficiency with Regulatory Information Management (RIM) systems.
• Technical Skills: Strong skills in Microsoft Office (Word, Excel), SharePoint, and other document management tools.
• Interpersonal Skills: Ability to work collaboratively within teams, handle compressed timelines, and prioritize multiple projects.

Application Link