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Online Resumes with "IND NDA ANDA"



Regulatory Affairs Associate, New Jersey

Regulatory Affairs professional with a strong regulatory and compliance foundation, well-versed in the laws, regulations and requirements of the FDA; over six years of experience as an International Coordinator for a pharmaceutical organization, currently completing a graduate degree in Regulatory Affairs in Drug Development, Biologics and Medical Devices, studying all facets of regulatory requirements including processes a...

Featured Profile

Pharmacist

Tags for this Online Resume: Regulatory submission, CMC, cGMP, Compliance, Regulations and Guideline, US FDA, medical device, IND/NDA/ANDA

Featured Profile

Global Regulatory Affairs - 14 Years of Experience- New Delhi India 110021

Seeking assignments as a Global Regulatory Affairs Professional - NCEs, GENERICS- Pharma, Biotech products, Botanicals & Medical Devices in Global Regions and/or Quality & Compliance professional across the Pharma & Medical Devices Industry. Overall Profile * With overall 15+ years industrial experience, with 14+ years in the field of Global Regulatory Affairs, Compilation & Submissions of Technical Packages for IND/CTA, ND...

Ideal Companies: BBraun Medical Pvt Ltd, New Delhi, India, Glenmark Pharmaceuticals Ltd., Mumbai, India, Panacea Biotec Ltd., New Delhi, India

Tags for this Online Resume: Regulatory Affairs, Management, Medical Devices, Pharmaceutical Industry, IND/CTA, Formulations & APIs, Regulatory Audits & Compliances, NCEs/NMEs/Generics, CT, Regulatory Consultancy, Regulatory Due Diligence & Gap Assessment

Clinical Quality Assurance

SUMMARY OF QUALIFICAITONS * Global and domestic cGxP operation, quality and packaging experience in medical/precision and diagnostic devices, pharmaceuticals and biomedical industries * Managed Chemistry and Manufacturing Controls: including API sourcing, vender/raw material qualification, formulation, product/process development, scale-up, clinical supplies, technology transfer and validation * Wrote and compiled CMC porti...

Tags for this Online Resume: Cancer, Consumer Products, Engineering, OTC, Process Engineering, Product Development, Risk Analysis, Commercial Production, Team Lead, API

Chemist - 13 Years of Experience - Near 07728

To obtain a challenging position in pharmaceutical industry involved in drug discovery and quality control that takes advantage of my experience in medicinal chemistry, organic synthesis and analytical laboratory skills. Willing to make an impact for the success and growth of a cutting edge company by utilizing my skills and experience. Professional Summary: * Experienced in medicinal chemistry, organic synthesis and qualit...

Tags for this Online Resume: Chemistry, Research, Sar