HomeRegulatory AffairsIntern GRA (Regulatory) | Eli Lilly & Company | Bengaluru

Intern GRA (Regulatory) | Eli Lilly & Company | Bengaluru

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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 39,000 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.

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At Lilly, we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world.  How do we do this? We continue to look for ways to include, innovate, accelerate, and deliver while maintaining integrity, excellence, and respect for people.​  We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

Position: Intern – GRA

Location: Bengaluru, Karnataka, India

Job Description:

Purpose

  • The CMC regulatory intern will support the implementation of the Regulatory Information Management (RIM) system. They will support data migration from existing regulatory databases to RIM. This role involves coordination with the RIM team and stakeholders at manufacturing locations and country affiliates.

Responsibilities:

  • Responsible to create tracking sheets for country affiliates to complete to reflect current CMC regulatory commitments.  Responsible for resolving discrepancies with regulatory commitments for those individual markets, handling documentation confirming compliance, and monitoring assessment completion due dates.
  • Responsible to complete complex spreadsheets with metadata from current submission documents to ensure accurate document migration.
  • Responsible to support submissions related to advertising and promotional material.
  • Support the management of the RIM training database by maintaining realistic scenarios at the appropriate step of the process in order for trainees to execute training exercises effectively.
  • Support CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD.
  • Support the submission management process to ensure all required electronic records are timely, complete, and accurate. Track affiliate submission and market approvals.

Minimum Qualification Requirements:

  • Postgraduate degree in health sciences discipline (e.g. pharmacy, chemistry or related scientific discipline).

Other Information/Additional Preferences:

  • Knowledge of the drug development process.
  • Demonstrated written, spoken, and presentation communication.
  • Demonstrated attention to detail.
  • Basic understanding of CTD structure for regulatory submissions.
  • Demonstrated ability to effectively prioritize and manage competing priorities and responsibilities.
  • Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.
  • Knowledge of MS Word and Adobe PDF.
  • Demonstrated effective teamwork skills; adapt to diverse interpersonal styles.
  • Ability to multi-task and work under tight timelines.
  • Proficient with Microsoft Word, PowerPoint, Excel, and Desktop Publishing Software.

 

Contact Details:

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