Global Regulatory Affairs

2 weeks ago

Bengaluru, India Eli Lilly Full time

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.

Global Regulatory Affairs - Intern

Purpose:
The Global Regulatory Affairs Intern is responsible for supporting activities for Lilly drugs, medical devices, and combination device products. The Intern resolves most questions and problems under supervision of senior colleagues. The Intern develops collegial, mutually productive relationships within the department and cross-functionally and embraces transformation initiatives.

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.
- Basic Knowledge of Regulatory Affairs
- Basic Knowledge of Heath Authorities submission guidelines i.e., European Union, US- FDA and Health Canada, TGA Australia, ICH guidelines etc.
- Knowledge of drug discovery & development
- Awareness of pre-clinical study design, protocol & clinical trials.
- Basic knowledge of drug packaging, labelling as per guidelines
- Ability to assess and manage risk in any situations. i.e during project work
- Strong written, spoken and presentation communication
- Attention to detail & Ability to prioritize projects.
- Effective teamwork skills; able to adapt to diverse interpersonal styles
- Ability to learn and use new software/technology.
- Ability to manage multiple tasks simultaneously.
- Working experience in MS office, Abode Acrobat

Minimum Qualification Requirements:

- Bachelor’s / master’s degree in a scientific or health sciences discipline (or equivalent experience).

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.

WeAreLilly

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