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Online Resumes with "NDA MAA"



Biochemist

Tags for this Online Resume: Regulatory Affairs , FDA EMA, NDA MAA, Compliance , Clinical - CMC, Leadership, Experienced IND CTA, Proficient- Pragmatic , Innovation

Director Regulatory Operations, Princeton, NJ

I am a regulatory affairs operations and publishing professional who has over 16 years experience in the publishing and management of Regulatory submissions. Expertise in the eCTD submission format for IND,NDA and MAA.

Tags for this Online Resume: ectd, regulatory, submissions, publishing, electronic applications, validation

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

Chemist - 20 Years of Experience - Near 02467

PROFESSIONAL SUMMARY * A proven leader with a track record of accomplishments with more than fifteen years pharmaceutical industry experience in leading analytical development activities for small molecule drug development * Hands-on experience in analytical project management in drug development and regulatory submissions hands- on experience in analytical method development/validation/transfer in GMP environments expertis...

Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Quantify, Analytical Chemistry, Chemistry, Research, Research and Development, Regulatory Affairs, Applications, CMOS, Development Activities