Vikas Kumar Dhiman
Vice President Regulatory Affairs @Syngene International Limited
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WORK HISTORY
Vice President Regulatory Affairs @Syngene International Limited
Bengaluru, IN
EDUCATION
Narsee Monjee Institute of Management Sciences (NMIMS)
Post-graduate Diploma, Business Management
Pantnagar University
Bachelors, Science
Academy of Clinical Excellence
Post-graduate Diploma, Clinical Research
ABOUT VIKAS KUMAR DHIMAN
Summary: A passionate and enthusiastic regulatory professional with 2 decades of extensive experience in Regulatory affairs; Government affairs & R&D activities viz. Regulatory Strategy & Operations, New Product Development [Innovation]; Drug Approval Strategy, Policy shaping, Advocacy initiatives, Stakeholder management & Relationship building for drugs, cosmetics, foods, medical devices, consumer products, ayurvedic products. Well versed with process of New product development, Regulatory science, New Drug Approvals, OTC medicines, Import & Registrations of Drugs, Cosmetics & Biologicals (including vaccines), Registration of foods, Ayurvedic products, Clinical Research & Post approval obligations including handling of Product Complaints, Anti-counterfeit drugs & Pharmacovigilance, across different therapeutic areas. Exposure/Experience of working with Government Agencies: NPPA, DoP, CDSCO, CDTLs, State FDAs, FSSAI, AYUSH, IPC, NIB, CDAC, CTRI, ICMR, CBN, NCB, IGISExposure/Experience of working with Industry Associations/Think Tanks:IPA, ASSOCHAM, FICCI, CII, ICRIER, ISCR, USIBC, IDMA, ADMA, IBHA, CBI, UKIBC, AESGPTop strengths:• Impeccable ethics • Negotiation skills• Relationship building • Attention to detail• Communication skills • Analytical thinking • Business support • Resilience & resolve • Strong IT skills
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