PRETOM CHAKRABORTY
Kolkata
Summary
Detail-oriented Regulatory Affairs aspirant with M.Pharmacy (Pharmacology) and foundational understanding of drug regulatory requirements. Familiar with CTD/eCTD format, regulatory guidelines, and documentation practices. Eager to apply academic knowledge and industry exposure to support regulatory submissions, audits, and lifecycle management.Regulatory Affairs Officer with pharmaceutical industry experience and a strong academic foundation in pharmacology. Experienced in regulatory documentation, SOP compliance, and coordination with production and quality teams. Adept at supporting product registration, variation submissions, and regulatory intelligence activities.
Overview
3
3
years of professional experience
Work History
Compliance Officer
Annora Pharma Pvt Ltd
Hyderabad
10.2024 - Current
- Regulatory Affairs Compliance professional with an M.Pharmacy (Pharmacology) and pharmaceutical industry experience. Knowledgeable in regulatory guidelines, compliance requirements, and documentation practices across product lifecycles. Experienced in maintaining regulatory records, ensuring adherence to SOPs and GMP standards, and supporting audits, submissions, and change control activities. Seeking to contribute to regulatory compliance, quality systems, and inspection readiness in a regulated pharmaceutical environment.
Internship Trainee
Bengal Chemicals and Pharmaceuticals Ltd
Kolkata
08.2022 - 07.2023
- - Managed granulation, coating, and packaging processes in the Tablet department for antibiotics of the Cephalosporins & Betalactum drug class. - Oversaw the documentation procedures for the Tablet department. - Handled tube filling and packaging operations in the Ointment department for Analgesics and Anti-microbials. - Executed bottle filling, packaging, and sealing activities in the Oil department for Cantharidine Oil and Aguru.
Education
Master of Pharmacy - Pharmacology And Toxicology
Avanti Institute of Pharmaceutical Sciences
Vizianagaram , INDIA 04.2001 -
Bachelor of Pharmacy - Pharmacy
Avanti Institute of Pharmaceutical Sciences
Hyderabad , INDIA 04.2001 -
Skills
- Regulatory Compliance (CDSCO, USFDA, EMA guidelines)
- CTD / eCTD Documentation & Dossier Compilation
- Regulatory Submissions & Lifecycle Management
- Change Control & Variation Management
- Labeling Compliance & Artwork Review
- Inspection Readiness & Audit Support
- Good Manufacturing Practices (GMP)
- SOP Preparation, Review & Compliance
Languages
Bengali
First Language
English
Proficient
C2
Hindi
Proficient
C2
Telugu
Upper Intermediate
B2
Certificatations
- NIDA Clinical Trials Network
Timeline
Compliance Officer
Annora Pharma Pvt Ltd
10.2024 - Current
Internship Trainee
Bengal Chemicals and Pharmaceuticals Ltd
08.2022 - 07.2023
Master of Pharmacy - Pharmacology And Toxicology
Avanti Institute of Pharmaceutical Sciences
04.2001 -
Bachelor of Pharmacy - Pharmacy
Avanti Institute of Pharmaceutical Sciences
04.2001 -