
Manasa User
@manasauser8
Regulatory operations candidate seeking to join Alcon, trained in CTD/eCTD submissions and regulatory document auditing.
What I'm looking for
At Aarogya Aadhaar, I verify data, audit regulatory documents, and manage clinical records across secure databases while maintaining data integrity and regulatory compliance.
I reconcile medical records and operational datasets in MS Excel, using VLOOKUP and Pivot Tables to identify discrepancies and maintain structured archives.
I also apply Root Cause Analysis and the Six Sigma DMAIC framework to improve documentation workflows and reporting accuracy, and compile weekly regulatory and operational summaries.
Through my B. Pharmacy studies and formal training, I’ve developed knowledge of ICH Guidelines, CTD/eCTD structure, Good Regulatory Practices, and dossier preparation. I’m seeking to contribute as an Associate I - Regulatory Operations at Alcon in support of quality standards and global health authority compliance.
Experience
Work history, roles, and key accomplishments
Healthcare & Data Analytics Intern
Aarogya Aadhaar
Mar 2026 - Present (6 months)
Executed data verification, regulatory document auditing, and clinical record management to maintain data integrity and compliance. Applied RCA and Six Sigma principles to streamline documentation workflows and compiled weekly regulatory reports.
Education
Degrees, certifications, and relevant coursework
European Open University
Professional Diploma in Pharmacology, Pharmacology
2026 - 2026
Completed Professional Diploma in Pharmacology.
CDSCO, WHO India & BRIC-THSTI, Govt. of India
Good Regulatory Practices (GRP) in Regulation of Medical Products, Regulatory Affairs
2026 - 2026
Completed Good Regulatory Practices (GRP) in Regulation of Medical Products.
Skill India / LSSSDC / NCVET
AI in Pharma: Transforming Life Sciences Through Technology, Artificial Intelligence in Pharma
2026 - 2026
Completed AI in Pharma: Transforming Life Sciences Through Technology.
Pharma Lesson Masterclass
Introduction to Pharmaceutical Regulatory Affairs & ICH Guidelines, Pharmaceutical Regulatory Affairs
2026 - 2026
Completed Introduction to Pharmaceutical Regulatory Affairs & ICH Guidelines.
Global GCP Clinical Standards
Good Clinical Practice (GCP) Certification, Clinical Practice
2026 - 2026
Completed Good Clinical Practice (GCP) Certification.
Cisco Networking Academy
Data Analytics Essentials, Data Analytics
2026 - 2026
Completed Data Analytics Essentials.
Sri Krupa Institute of Pharmaceutical Sciences
Bachelor of Pharmacy, Pharmacy
2022 - 2026
Grade: 8.13/10.0 CGPA
Pursued Bachelor of Pharmacy with a CGPA of 8.13 out of 10.0.
TS Model Junior College
Intermediate (12th Standard), BIPC
2020 - 2022
Grade: Grade A
Completed Intermediate (12th Standard) in BIPC with Grade A.
Kakatiya High School
Secondary School Certificate (10th SSC), General
2019 - 2020
Grade: 10.0 GPA
Completed Secondary School Certificate (10th SSC) with a 10.0 GPA (100%).
Availability
Location
Authorized to work in
Salary expectations
Social media
Job categories
Skills
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