BHARATLAL SAIN
Bengaluru
Summary
CMC regulatory affairs professional with 4+ years of experience in injectable drug products, including extended-release suspensions, pre-filled syringes, lyophilized powders and complex injectables. Skilled in compilation of dossiers for generic drug applications. Experienced in reviewing regulatory documents, responding to health authority queries, and maintaining regulatory databases.
Overview
5
5
years of professional experience
Work History
TEAM LEADER
MYLAN LABORATORIES LIMITED (A VIATRIS COMPANY)
03.2025 - Current
- Manage the new submission CMC CTD dossiers for a wide range of injectable drug products such as extended release suspensions, pre-filled syringes, solution for injections, lyophilized powder and complex injectables.
- Technical review of the product dossiers [Module 1 to Module 3] in compliance with relevant international standards for generic drug applications.
- Review responses to queries from health authorities
- Identify potential issues related to product registration and reported to the management for proactive resolution
- Develop and maintain a database of regulatory information for assigned products.
- Review of variation dossier and handling of change management system, Trackwise.
SENIOR EXECUTIVE
MYLAN LABORATORIES LIMITED (A VIATRIS COMPANY)
09.2021 - 02.2025
- Compilation and review of CMC dossiers for a wide range of injectable drug products such as extended release suspensions, pre-filled syringes, solution for injections, lyophilized powder and complex injectables.
- Compile product dossiers [Module 1 to Module 5] in compliance with relevant international standards for generic drug applications in Emerging market regions including MENA, LATAM, ASIA and GCC regions.
- Compile and review responses to queries from health authorities.
- Prepare and submit responses to questions/queries from global health authorities regarding regulatory matters, maintaining compliance and timely submissions.
- Compile and review technical data (certificate of analysis, stability data, process validation etc.) for submissions according to current health agency requirements and ICH guidelines, ensuring timely, high-quality submissions that minimize deficiencies and accelerate product approvals.
- Review of change controls for under approval and approved drug products ensuring compliance of submission dossiers to current guidelines (ICH and health authority requirements).
- Develop and maintain a database of regulatory information for assigned products.
- Compilation of minor and major post approval variation dossier and handling of change management system, Trackwise.
ASSOCIATE TRAINEE
MYLAN LABORATORIES LIMITED (A VIATRIS COMPANY)
09.2020 - 09.2021
- Review of technical documents, including batch manufacturing records, process validation reports, drug substance and drug product specifications, and stability protocols and reports, in-use stability protocols and reports, with the regulatory standards.
- Collaborated with team members to compile new submission and post-approval variation dossiers for regulatory filings.
- Understood the post approval guidelines for the Emerging and Europe region.
- Acquired a comprehensive understanding of the drug product labeling requirements for various geographies, ensuring alignment with regulatory guidelines.
Education
M. Pharm - Pharmaceutics
JSS College of Pharmacy
05.2020
B. Pharm -
Srinivas College of Pharmacy
05.2018
Skills
- Effective communication
- Efficient knowledge retention
- Collaborative team member
- Simultaneous project handling
- Effective time management
- Attention to detail
- Chemistry manufacturing & controls
- Sterile products
- Complex injectables
- ICH
- Trackwise
- Docubridge
- D2 Documentum
- MS PowerPoint
- MS Outlook
- MS Excel
Hobbies
- Reading
- Playing cricket
- Listening to music
- Cooking
Personal Information
- Date of Birth: 09/09/96
- Gender: Male
- Nationality: Indian
Timeline
TEAM LEADER
MYLAN LABORATORIES LIMITED (A VIATRIS COMPANY)
03.2025 - Current
SENIOR EXECUTIVE
MYLAN LABORATORIES LIMITED (A VIATRIS COMPANY)
09.2021 - 02.2025
ASSOCIATE TRAINEE
MYLAN LABORATORIES LIMITED (A VIATRIS COMPANY)
09.2020 - 09.2021
M. Pharm - Pharmaceutics
JSS College of Pharmacy
B. Pharm -
Srinivas College of Pharmacy
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