Samit Sajjad FM

Achieving position where education and experience combined with positive interpersonal skills, initiating and the capacity to motivate others can be utilized for mutual benefit. Seeking a challenging career that shall help to use my acquired skills and advance myself to quality in work and upgrade as per new innovations.

Regulatory Affair Executive - Prosfora Technology Pvt Ltd. - Powane MIDC, Navi-Mumbai

(2023-04)

• Review and compilation dossier for specific country Europe, SAHPRA, Chile, Ukraine, in CTD/ACTD/eCTD, validation through Lorenz software.
• Preparation all regulatory related documents Dossier (M1,M2,M3,M4 & M5 eCTD).
• Understanding of requirements & regulation of Chile, Europe/UK, SAHPRA, Ukraine, African market, submission, & RRA submission.
• Preparation of all annexure for SAHPRA-BTIF, QOS, QIS, Abridge review.
• Details review of technical documents required for submission e.g. PVP/PVR/AMV/Stability report & protocol/specification/COAs, BE study & DMF etc.
• Co-ordinate with plant for required documents/ samples/working standard etc through mail/phone call.
• Artwork checking.
• Preparation of DB summary tables for regulatory module 2.
• Data Analysis & Programming: Writing SAS programs to calculate PK parameters (AUC, Cmax) and perform statistical analysis, often using Proc GLM or Proc Mixed, Pharmacokinetic (PK) Analyst, statistical methodologies (ANOVA, Confidence Intervals) for crossover studies.
• Performing literature serve using various reviews, journals, Abstracts, labels, Product monograph etc. for the preparation of protocol for submission.
• Doing Bio clinical Study Facility Audit.

Regulatory Affair Executive-CRA - Anazeal Analyticals & Research Pvt.Ltd. - Thurbe MIDC, Navi-Mumbai

(2019-03 - 2023-03)

• Preparation all regulatory related documents (m2 module- summary and m5 module).of CTD, eCTD for clinical study reports (m5 module).
• Preparation and review of clinical study report, CRF, ICF, DMF as per the ICH E3.
• Preparation and review of clinical and bioanalytical protocol as per method development.
• Statics PK Calculation, report preparation.
• Preparation of bioequivalence trial information, Asian Index, trail master file.
• Preparation of drug substance and drug product module 3.2.S and 3.2.P.
• Clinical study report writing for regulatory, USFDA, LATAM, and ROW, DCGI.
• Preparation of DB summary tables for regulatory module 2.
• Performing literature serve using various reviews, journals, Abstracts, labels, Product monograph etc. for the preparation of protocol for submission.
• Preparation of Method Validation Report, Protocol, Subject Analysis Report and Final Report. CSR report preparation.
• Dosing, dispensing, of investigational drug BA/BE study trials.
• Subject Analysis Study Report preparation.
• Face USFDA Audit.
• Face DCGI Audit.

Clinical Pharmacist - APM Terminal Mumbai (Jnpt Port Trust) Csr Project, Hajwane's Healthcare Pvt. Ltd. - Mumbai

(2018-05 - 2019-03)

• Providing medicines to off shore marine.
• Medicines purchasing as per requirement.
• Check prescription orders from hospital, review narcotic reconciliations, dispense, and verify medication in compliance with state federal regulation.
• Mange drug inventory assist with drug file maintenance.
• Assist with quality improvement initiative.

Medical coder, SAS programmer - E4E healthcare Pvt ltd (nThrive.com) - Chennai

(2015-04 - 2017-03)

• Analytical solution to clients (coding analysis, denial coding analysis).
• Handling project "Optimax", denial coding, radiology coding.
• Quality analysis.
• Client Interaction.

Pharmacist - J.J.MEDICAL - opp j. j. hospital, Mumbai

(2013-07 - 2015-02)

• Check prescription orders from nursing home, review narcotic reconciliations, Dispense, and verify medication in compliance with state federal regulation.
• Mange drug inventory assist with drug file maintenance.
• Assist with quality improvement initiative.

Certification - SAS Programming - Base SAS programming and Clinical SAS programming (2023 - 2023)

Advanced Post graduation diploma - Regulatory Affairs - Unknown (2021 - 2022)

Certification - Pharmacist - Qatar council for Healthcare Practitioner (2017 - 2017)

Post-Graduation Advanced Diploma - Clinical Research & Pharmacovigilance, SAS - ICRI MUMBAI (2014 - 2015)

Bachelor in Pharmacy - B. pharm - ALLANA COLLEGE OF PHARMACY (2013 - 2013)

Diploma - Pharmacy (D. pharm) - Mumbai board (MSBTE) (2009 - 2009)

Higher Secondary Examination - HSC - ANJUMAN ISLAM MURUD JANJIRA, Maharashtra board (2007 - 2007)

Secondary School - SSC - Maharashtra Board (2005 - 2005)