Qualification: M.Sc in Analytical Chemistry by research from Mumbai University, Diploma in Drugs Regulatory Affairs
Worked in companies: Cipla Ltd, Watson Pharma Pvt Ltd, FDC Ltd (includes API and Formulations like OSD, Ophthalmic, ORS, Topical)
Worked in departments: Quality Control and Quality Assurance and very close support to Regulatory cell in submissions and queries handling.
Key skills: Good Documentation Practices, Good investigation skills in events like OOS, OOT, Deviations, Complaints, analytical incidences, Documentation involved in SMF, VMP, products recall / complaints, self inspection, Good Training and Co-ordination skills.
Training given on various technical topics as well as on administration / communication skills
Training undergone: Auditors training (3 days course), attended many workshops in India on technical aspects like Stability study, CAPA, Investigations, Training on Chromatography in Singapore at Shimadzu and Agilent.
Dr.Manjusha Rajarshi
Academic Qualifications:
Masters’ Degree in Pharmaceutical Sciences, (University of Mumbai)
Doctor of Philosophy – (Pharmacology) (University of A.M. Kolkata)
Diploma in IPR- Patents, Trademarks and Copyright (Bioinformatics Institute of India)
Basic statistical analyses, advance statistical courses from CMC, Vellore
Currently pursuing the course in Public Health (elective specialization NONCOMMUNICABLE
DISEASES) at Public Health Foundation of India, New Delhi
Work Experience:More than 20 years in the pharmaceutical industry (various companies –Serdia, Bayer, Aventis Pasteur, Unichem, B. Braun);
Career began in sales and marketing department as a “Management Trainee”.
Various career moves from training department, medical department, clinical operations and regulatory affairs and medical affairs.
Therapeutic areas handled:
cardiology, diabetology and metabolism, venous diseases, neuro-psychiatry, vaccines and other internal medicinal therapies.
Publication published on behalf of the employers: more than 25; majority in international journals such as IJCP, American Journal of Cardiovascular Drugs, Neurology, International Journal of Cardiology, Diabetes Research etc.
Job Responsibilities Held:
Responsible for domestic and international clinical studies
Regulatory affairs
Patents and Trademark issues
Pharmacovigilance
Biostatistics and statistical analyses
Medical writing and publications
Medical Affairs and information services
Doctor contacts, opinion leaders’ contacts and contacts with major governmental and non-governmental institutions (Cardiologists, Diabetologists, internists, neurologists, psychiatrists etc.)
Membership and affiliations:
Pharmacy Council of India (PCI), registration number 1988/ 3080
Indian Society of Clinical Research (ISCR), life member
Indian Association for Statistics in Clinical Trial, Life member
Teaching assignments:
Module developer with Academy of Clinical Excellence
Topics covered Regulatory Module; teaching assignments Indian, US, European, Australian and Japanease Guidelines (visiting faculty)
Module developer with MUHS, for M.Sc in Clinical Research
Topics covered Regulatory and Ethical considerations; teaching assignments with MUHS and also examiner and moderator for M.Sc.Part II
Visiting faculty:
SVKM’s NMIMS University, School of Pharmacy and technology management; subject covered “Regulatory, Compliance and applied ethics”.
