Global Regulatory Affairs Specialist ELC Group Appoints Senior Regulatory Expert
4/3/2014 2:20:48 PM
Accomplished Biosimilars regulations manager Jin-Hee Kang joins ELC Group
Cambridge, UK, 3rd April 2014 – ELC Group, one of the fastest-growing providers of regulatory affairs, today announces the appointment of Jin-Hee Kang as Senior Regulatory Expert specialising in Biosimilars. Jin-Hee Kang will be leading on support for Biosimilars development, focusing on legislative changes surrounding market launch.
A former Associate Senior Director for Central Research Institute RA/CO with Celltrion Pharmaceuticals, Inc., Jin-Hee Kang was previously one of the key leaders behind the first monoclonal antibody biosimilar registration within the EMEA region, supervising the marketing authorisation from the feasibility studies to full launch logistics in over 130 countries.
She previously worked with Otsuka Pharmaceutical, Inc. as RA Manager for six years. Her facilitation of new drug approval and launch accomplished a 150 per cent growth in the Asia and Arab markets in just two years.
Speaking about the appointment, ELC Group's Head of Market Intelligence & Business Development, Akhil Jain said: "We offer Jin-Hee the warmest welcome to ELC Group and are excited with this new appointment. Kang has proved herself an expert in regulatory affairs over large geographies and we are confident in the growth of ELC Group’s Biosimilars business area under her supervision."
Jin-Hee commented: "I am thrilled to be joining ELC Group as a Senior Regulatory Expert. ELC Group is one of the fastest growing industry experts and I look forward to working with the team in ensuring exemplary service when taking our clients’ products to market.”
Kang studied Oriental Language Chinese at Hankuk University of Foreign Studies, Korea and is an accomplished linguist.
ajain [at] elc-group [dot] com
Phone: +420 22 491 00 00
nicky[at] evokedset [dot] com
Phone: +44 (0)7747 017654
About ELC Group:
ELC GROUP is a full-service global provider of regulatory affairs consultancy. ELC GROUP delivers a complete service solution covering all aspects of Regulatory Affairs for medicinal products, medical devices, cosmetics, food supplements and foods for special medicinal purposes. ELC GROUP also provides specialist REACH regulatory services to the Chemical industry and Corporate Language solutions for Automotive, Chemical and Defense industries.
ELC GROUP’s worldwide network of professionals spans all major Regulatory Affairs services across the key healthcare vertical markets of Pharmaceuticals, Biotech, Clinical, Consumer Healthcare, Medical Devices, Nutraceuticals and Veterinary. The team ranges from former FDA investigators to individuals with over 30 years of industry experience and broad capabilities, including in the areas of integrated advanced technologies, Regulatory Affairs consulting and commercialisation services.
ELC GROUP works with equal success in partnership with large multi-nationals, small enterprises and start-ups, biotechs, CROs and device manufacturers.
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