Maithili Kali
Assistant Manager, Regulatory Affairs
Khamla, Nagpur
Summary
Focused and adaptive regulatory affairs professional with around 2 years of experience in delivering timely submissions by collaborating with cross functional teams.
Overview
2
2
years of professional experience
2
2
years of post-secondary education
Work History
Assistant Manager
Regulatory Affairs
Mumbai
12.2020 - Current
- Achieved successful product launches (generics) in Europe and US markets
- High proficiency in writing CMC Module 3, Module 2 (QoS) for end to end CTD submission
- Provided technical and scientific reviews on documentation and presented appropriate responses for quality and integrity compliance
- Delivered renewals, variations and submissions ROW markets
- Headed major internal project of manufacturing site transfer variations for multiple countries and products
- Systematized deficiency response of Quality part for EMA submission and responded to queries received by customers and local agencies
- Awarded Applause Spot Recognition in Q2 FY2022 for critical review, time management, effective communication and business continuity for above projects.
Education
Master of Pharmacy -
BITS Pilani
Pilani 08.2018 - 07.2020
Skillset
- Technical: Microsoft office (Word, Excel), Documentum, TrackWise, Adobe pdf editor
- Functional: Gap analysis, Technical writing, Technical review
- Personal: Intrapersonal skills, decision making, time management
Accomplishments
Mentored a team of 4 for a Multidisciplinary National Research project competition organized by Indian Pharmacy Graduates Association and secured third position
Courses
- Introduction to Clinical Research issued by The Global Health Network
- General course on Intellectual Property rights issued by World Intellectual Property Organization – WIPO
- Design of experiment for product, process and quality manager issued by Udemy
Timeline
Assistant Manager
Regulatory Affairs
12.2020 - Current
Master of Pharmacy -
BITS Pilani
08.2018 - 07.2020
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