SR. Manager Regulatory Affairs EU UK & ROW Market
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About 25 years of experience (from Aug.1998 till date) including 4 years in Quality Control and. Well versed in preparation, review, submission, registration document / Dossier in India, International Market, ROW countries, in CTD/A-CTD format as per country specific requirement. Key knowledge includes preparation for pharmaceutical dossier for India and International market, registration of pharmaceutical product in Europe (Portugal, Germany, Czech Republic, Slovenia) & UK, registration of pharmaceutical product in Kenya, Uganda, Tanzania, Ethiopia, Zambia, Zimbabwe, Botswana, good knowledge Europe e-CTD preparation and submission, participation in WHO prequalification Geneva, Switzerland, well versed with CTD/e CTD and A-CTD format, having good knowledge with CDSCO submission, having good knowledge with C.I.S Countries (Russia, Ukraine, Uzbekistan, Turkmenistan, Kazakhstan, Georgia, Armenia), submission to South East Asia (Cambodia, Myanmar, Malaysia, Philippines, Vietnam, Taiwan, Singapore), submission to Australia, New Zealand, Brazil, Canada, South Africa.
Sr. Manager Regulatory Affair at NV Remedies Pvt. Ltd. (2024-07 – Present)
Type of drug manufacturing: Tablet, Injectable, Capsules, Cream & Ointment, Orodispersible Film. Countries: Ukraine, Kazakhstan, Malta, Latvia, Portugal, Croatia, Estonia, Czech Republic, Slovenia, Bulgaria, Germany, France, Netherland, Cyprus & UK.
Sr. Manager Regulatory Affair at Rusan Pharma Pvt. Ltd. (2020-10 – 2024-07)
Type of drug manufacturing: Tablet, Injectable, Capsules, Cream & Ointment, Transdermal Patches.
Countries Europe: INFARMED (Portugal), Federal Ministry of Health (Germany), State Institute of Drug Control (Czech Republic), JAZMP (Slovenia), National Health Service (N. Ireland), MHRA (UK).
African Countries: Kenya, Tanzania, Uganda, South Africa, Ethiopia, Zambia, Zimbabwe, Botswana.
CIS Countries: Russia, Ukraine, Uzbekistan, Turkmenistan, Kazakhstan, Georgia, Armenia.
South East Asia: Myanmar, Malaysia, Philippines, Vietnam, Taiwan, Singapore. Submission to Australia, New Zealand, Brazil, Canada, South Africa. Participation in WHO prequalification Geneva, Switzerland.
Manager Regulatory Affair at M/S. Shalina Laboratories Pvt. Ltd. (2015-04 – 2020-10)
Type of drug manufacturing: Tablet, Injectable, Capsules. Countries: Ghana, Nigeria, Kenya, Zambia, Benin, Togo, Mali, Democratic Republic of Congo.
Manager Regulatory Affair at M/S MJ BIOPHARMA Pvt. Ltd., MIDC, Taloja (2011-12 – 2015-03)
Type of drug manufacturing: Tablet, Injectable, Capsules. Countries: Romania (NMA- Europe), S.Africa (MCC), Russia, Kazakhstan, Botswana, Zambia, Vietnam, Myanmar.
Regulatory Affair executive at M/S Themis Lab LTD, Thane (2007-08 – 2011-12)
Type of drug manufacturing: Tablet, Capsule, Powder. Countries: Thailand, Singapore, Philippines, Cambodia, Kenya, Tanzania.
R.A. Executive at Aviat Chemical Pvt. Ltd., Juinagar (2002-06 – 2007-07)
Type of drug manufacturing: Liquid. Countries: Uganda, Brazil, Peru, Shri Lanka, Nepal, Kenya, Tanzania.
Q.C. Officer at M/S Rusi Remedies Pvt. Ltd., Vasai (1998-08 – 2002-05)
Type of drug manufacturing: Liquid, Tablet, Capsule, Injection.
M.Sc. in Chemistry – Vinayak Mission University (2011)
B.Sc in Chemistry – Mumbai University (1998)
HSC – Mumbai University (1995)
SSC – Mumbai University (1993)
