Job Description
About Lilly & Our
Purpose
Eli Lilly and Company is an
American pharmaceutical
company headquartered in
Indianapolis, Indiana, with
offices in over 18 countries. Its
products are sold in
approximately 125 countries.
The company was founded in
1876 by, and named after,
Colonel Eli Lilly, a
pharmaceutical chemist and
veteran of the American Civil
War.
Lilly has had many
breakthrough medicines in its
over 147 years of existence –
for example, it was the first
organisation to make
commercially viable Insulin.
Lilly works in the areas of
Diabetes, Oncology,
Neuroscience, Immunology
and more.
Lilly Capability Center India
(LCCI) is the Bangalore
Research & Development unit
of Eli Lilly. LCCI has various
capabilities involved in drug
research & development
process.
Our purpose is to unite caring
with discovery to make lives
better for people around the
world. In doing so, each
individual working with Lilly
indirectly impacts millions of
lives.
Job Title -
Global Regulatory Affairs – Intern
About the function
GRA work encompasses the entire product lifecycle from
Research & Development → To Market Withdrawal. Key
Responsibilities of Global Regulatory Affairs is to develop and
execute regulatory strategy, collaborate with Lilly colleagues, and
lead interactions with Regulators. GRA has deep expertise in
regulatory sciences, drug development, and the business
provides the ability for the GRA team to quantify risk and
uncertainty in the context of business constraints and emerging
science in order to help influence decision-making by Lilly
leaders by offering alternate strategies and solutions that
improve probability of success.
Qualifications required.
Bachelor’s / master’s degree in a scientific or health sciences
discipline (or equivalent experience).
Skillsets required.
• Knowledge of Drug and Device Regulatory Affairs
• Understanding of regulatory framework and knowledge of
guideline from European Medicines Agency, US Food and
Drug Administration, Health Canada, Therapeutic Goods
Administration, Australia, International Conference on
Harmonisation (ICH) etc.
• Knowledge of drug discovery & development
• Awareness of pre-clinical study design, protocol & clinical
trials.
• Knowledge of drug packaging and labelling 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, Adobe Acrobat
Takeaways from the role for the candidate:
• Subject Matter Expert knowledge within assigned GRA
function.
• Planning and execution of product lifecycle using
available platforms (document management system, MS
teams, SharePoint)
• Stakeholder management and work prioritization
• Leveraging technical and regulatory expertise for better
results in day-to-day deliverables.