Sanika Sanjay Karnik
Banglore
Summary
Aiming to leverage my scientific skills, educational background, and ability to work well with people to successfully fill the role of a pharma market Regulatory Affairs Associate.
An efficient Submission Coordinator with experience in registrations of various drug products in different geographical regions worldwide for wide range of therapeutic portfolios. Expertise in diverse submission delivery via RIM-Veeva Vault. Supported over 15+ major Initial submissions for various therapeutic portfolios in collaboration with affiliates. Taking complete ownership, meeting the submission delivery timeline, and consistently providing quality submissions have been my primary goals during my tenure. Highly adaptive with excellent time management skills and keen to work in challenging environments which would allow me to expand my knowledge.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Analyst
Eli Lilly Services India Pvt Ltd
08.2023 - Current
Analyst
Eli Lilly Services India Pvt Ltd
Banglore
01.2023 - Current
- Joined Lilly as an intern in the CMC Regulatory Team to lead the CMC submission management process, providing knowledge of ICH CTD.
- Collaborating with the CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products.
- Literature reviewing and evaluation of various documents for each molecule in the pre-development phase for Module 3 with the MSPs.
- Partner with the affiliates over different geographical regions to execute timely submissions for Europe (EU), Saudi Arabia, Oman, Qatar, Bahrain, the UAE, and Great Britain (UK).
- Responsible for the registrations of the newly launched products in different geographical regions.
- Handle different types of submissions, such as Initial (New Chemical Entity), Renewal of Marketing Authorization, Type I Variation, Type II Variation, Post-Approval Commitments, and Response to Questions (RTQs).
- Knowledge of 510(k) pre-market notification, and Health Canada.
- Understanding the working knowledge of medical device regulations for FDA laws and Health Canada.
- Arranging meetings with the stakeholders and regulatory scientists to understand the technicalities of the project, to execute timely completions of the regulatory submissions.
- Collaboration with stakeholders, CMC, and the Non-clinical Team for Modules 1, 3, and 4 documents, respectively.
- Updating metadata correctly, as per regional requirements.
- Excellent knowledge in the creation of a Master Content Plan (MCP), copying the content plan in RIM, and creating and updating submission joints.
- Responsible for advertisement, promotional, and labeling (AD-Promo) submissions for different therapeutic portfolios through RIM in the United States.
- Structured way of working.
- Good communicator and team player who can work in a flexible, goal-oriented environment.
Education
M. Pharm - Pharmacology
BITS Pilani
01.2023
B. Pharm -
NMIMS
01.2021
Skills
- Project Management
- Leadership
- Strategic Planning
- Communication
- Problem Solving
- Veeva Vault-RIM
- Quality Docs Production
- E-CTD
- Lorenz e-validator
- ISM Publishers
- MS Office
- Data Interpretation
- Market Dynamics
- Stakeholder Engagement
Certification
- Tableau Essential Training.
- Foundations of Project Management- Google.
- Understanding how Medical Devices are regulated in Canada- Health Canada.
Publications
- Drug Pipeline for Obesity Therapy, https://doi.org/10.1007/978-3-030-53370-0_68
- Novel Gene Therapy Approaches for Targeting Neurodegenerative Disorders: Focusing on Delivering Neurotrophic Genes, https://doi.org/10.1007/s12035-024-04260-y
Timeline
Analyst
Eli Lilly Services India Pvt Ltd
08.2023 - Current
Analyst
Eli Lilly Services India Pvt Ltd
01.2023 - Current
M. Pharm - Pharmacology
BITS Pilani
B. Pharm -
NMIMS