Senior CMC Consultant @ (September 2015 - February 2016)
Regulatory Consultant @ (March 2015 - September 2015)
CMC Consultant (EMEA) - Tech Transfer @ (June 2014 - December 2014)
EU Regulatory Affairs @ (February 2014 - May 2014)
CMC Conformance Manager - EU and African Markets (Contractor) @ (March 2013 - February 2014)
Regulatory Consultant - Labelling and Pharmacovigilance Project (Contractor @ (January 2013 - April 2013)
Regulatory Affairs Executive @ (January 2012 - January 2013)
Clinical Project Associate @ (June 2011 - January 2012)
Clinical Project Coordinator @ (August 2010 - September 2010)
Research Intern @ (August 2010 - August 2010)
Research Internship @ (June 2010 - August 2010)
Customer Service Executive @ (October 2007 - September 2008)
Rohit Kulkarni Education
IU International University of Applied Sciences
Master of Business Administration - MBA
2021-2023
University of Portsmouth
BSc (Hons) (Biomedical Science)
2008-2011
The Henley College
International Baccalaureate Diploma
2005-2007
Rohit Kulkarni Skills
Biotechnology
Business Development
CMC Regulatory Affairs
CTD
CXO level engagement
Clinical Development
Clinical Research
Clinical Trials
Consumer Healthcare
Corporate Governance
Drug Design
Drug Development
Drug Discovery
Drug Safety
Electronic Common Technical Document (eCTD)
Emerging Markets
Ethics Submissions
GCP
GMP
Gap Analysis
Generic Drugs
Global Regulatory Compliance
ICH guidelines
ICH-GCP
Infectious Diseases
Life Sciences
MRP
Management
Medical Devices
Neurodegenerative Disease
OTC
Oncology
Oncology Clinical Research
Operations Management
PIL
PIL User Testing
Pharmaceutical Industry
Pharmaceutical Manufacturing
Pharmaceutics
Project Management
Regulatory Affairs
Regulatory Agencies
Regulatory Guidelines
Regulatory Requirements
Regulatory Strategy Development
Regulatory Submissions
SmPC
Spanish
Standard Operating Procedure (SOP)
Strategy
TMF
Team Management
Technology Transfer
Variation
Venture Capital
Rohit Kulkarni Summary
Rohit Kulkarni, based in United Kingdom, is currently a Policy Research - Emerging Voices Network (EVN) at BASIC (British American Security Information Council). Rohit Kulkarni brings experience from previous roles at Regulex Consulting Ltd, MRP Advisory and Aanya Wellness. Rohit Kulkarni holds a 2021 - 2023 Master of Business Administration - MBA @ IU International University of Applied Sciences. With a robust skill set that includes Biotechnology, Business Development, CMC Regulatory Affairs, CTD, CXO level engagement and more. Rohit Kulkarni has 2 emails on RocketReach.
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