Suhas Shankar Joshi
Bengaluru
Summary
Accomplished professional with expertise in performance improvement and strategic growth planning to achieve business objectives. Demonstrates strong leadership and communication skills, with a proven track record in regulatory compliance, eCTD submission, and labelling management. Committed to leveraging active listening and leadership abilities to drive organisational success and ensure adherence to industry standards.
Overview
5
5
years of professional experience
Work History
Senior Executive
Onesource Specialty Pharma Limited (Formerly known as Steriscience Specialties Private Limited)
Bengaluru
04.2024 - 02.2026
- Maintaining US Labeling activities
- Maintaining Life cycle activities and post approval changes
- ROW market Submissions
- Review and approve master documents(MFR, MPR, Stability protocols) to ensure alignment with regional and global requirements
- Managing end to end regulatory life cycle management ( i.e annual reports, PADER's)
- Preparation of CMC documents for ANDA/dossier submissions(injectables)
Executive
Steriscience Specialties Private Limited [ Injectables]
Bengaluru
03.2022 - 03.2024
- Responsibility of preparation and submission of regulatory filings of ANDA'S to FDA for new product approvals
- Prepared and submitted labeling changes, and post-marketing Changes i.e CBE 0, CBE30
- Coordinated with cross-functional teams to ensure timely and accurate submissions
- Responded and resolved to FDA queries and provided necessary information to support regulatory submissions and receive approvals.
- Well experienced in eCTD activity in Educe application
- Maintaining Life cycles activities for approved applications, Such as PADER reports and Annual reports for US-FDA
- Responsibility of preparation and submission of Control Correspondence
Trainee - Regulatory Affairs & Quality Assurance
Pharmaleaf India Private Limited [Regulatory Consultancy]
Bengaluru
04.2021 - 03.2022
- Knowledge of Regulatory Information and Intelligence to support filing strategy and Regulatory classifications for CDSCO
- Review and Gap Analysis of Dossier for adequacy of submission
- Communication with clients and updates on projects milestone to the clients post discussion with reviewers.
Education
M.Pharm - Pharmaceutical Regulatory Affairs - Regulatory affairs
JSS College of Pharmacy, Mysuru
2021
B.Pharm - Pharmacy
HKE's College of Pharmacy, Gulbarga
2019
Skills
- Regulatory compliance
- eCTD submission
- Labeling management
- Communication skills
- Active listening
- Leadership
- Willingness to learn
- Cross-functional collaboration
Languages
Kannada
Proficient
C2
English
Proficient
C2
Tamil
Beginner
A1
Hindi
Proficient
C2
Telugu
Intermediate
B1
Timeline
Senior Executive
Onesource Specialty Pharma Limited (Formerly known as Steriscience Specialties Private Limited)
04.2024 - 02.2026
Executive
Steriscience Specialties Private Limited [ Injectables]
03.2022 - 03.2024
Trainee - Regulatory Affairs & Quality Assurance
Pharmaleaf India Private Limited [Regulatory Consultancy]
04.2021 - 03.2022
M.Pharm - Pharmaceutical Regulatory Affairs - Regulatory affairs
JSS College of Pharmacy, Mysuru
B.Pharm - Pharmacy
HKE's College of Pharmacy, Gulbarga