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Online Resumes with "IND NDA"



Consultant - Regulatory Affairs, NJ

Seeking Regulatory Affairs position where 20+ years of experience in pharmaceuticals Regulatory Affairs and R&D will add value.

Tags for this Online Resume: RAC Certification, Microbiology and fermentation, toxicity assays high-throughput screening, CMC, project and staff management, submissions, compliance, IND NDA submissions, Consultant, molecular microbiologist, toxicity assays , project management, submissions, compliance, IND/NDA/eCTD, regulatory, pharmaceuticals, regulatory scientist

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...

In-vivo Pharmacologist

Extensive years of experience in the research, planning and implementation of in-vivo models in the Respiratory, Inflammatory and Oncology areas. Project management for various drug development models. Exceptional analytical and problem solving skills. Highly motivated, with the demonstrated ability to conduct independent research related to the successful development of pre-clinical and IND/NDA candidates.

Tags for this Online Resume: pharmacology, in-vivo, animal, dosing

Featured Profile

Featured Profile

Principal Scientist/Analytical Project leader

Seek position in R&D as a analytical development team leader handling multiple projects, coordinate project activities with various departments (quality assurance, Reg. CMC, Clinical Manufacturing Unit, Drug supply management, technical operations and outside contract laboratories. Direct analytical method development and oversee analytical development for the formulation development at contract labs

Tags for this Online Resume: Publications, Diagnostics, Pharmaceutical, Research, Research and Development, Support, Technical Support, Audit, Compliance, Medical

Senior Microbiologist

I'am a Senior Microbiologist who has over 11 years of experience in planning, executing and managing clinical and non-clinical studies in Microbiology required for IND or NDA by FDA; isolation and identification of microorganisms, antimicrobial susceptibility testing by CLSI approved procedures.

Energetic, results-oriented individual with established credibility and respect at FDA and EMA. An extraordinary record which includes the lead and approval on New Drug Applications (NDA) and Marketing Authorization Application (MAA)

Global Regulatory Affairs leader for a combination of RA functions. Provides clear and specific regulatory input using skills(scientist, regulator and lawyer) to provide strategic planning decisions and implementation enabling successful drug approvals. Strong leader, expertise in DD, alignment with business goals, creative, proficient with complex frameworks and integration of abstract concepts in clinical and CMC areas o...

Tags for this Online Resume: Regulatory Affairs, small molecules, CDER, CBER, FDA, EMEA, IND, NDA, CTA, IMPD, proteins, anti-infectives, cardiovascular, pain, oncology, CMC, compliance, communicator, monoclonal antibodies , Biologics, Food and Drug, Global, eCTD, health authorities, alliance management, combination products, Biologics Biosimilars , Director , pharmaceutical , Leadership, Problem solving , Innovation, experienced, IND NDA CTA MAA, business goals , biologics - pharmaceutical , biosimilars

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

Passionate Creative Drug Development professional-17 years experience from discovery to POC, - open to relocation

Seeking a leadership position on a world class team translating preclinical safety and efficacy findings into IND/NDA enabling strategies to support development of new therapeutic agents or drug/device combinations.

Tags for this Online Resume: Pre-clinical, preclinical, nonclinical, Pharmacology, Toxicology, Neuroscience, Drug Development, Safety Assessment

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Quality Coordinator - 14 Years of Experience - Near 10603

I am looking for something new and challenging where a company is willing to train someone in a new field to grow and contribute to the company's goals.

Ideal Companies: Pharmaceutical, medical device, Biotech, healthcare

Tags for this Online Resume: Regulatory Affairs, Quality Assurance, Drug Safety, Medical Documentation specialist, Submisisons operations, FDA compliance, Annual Reports, project leader

Pharmacist

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

Clinical Quality Assurance - 20 Years of Experience - Near 94403

QA/QC experience working with FDA ICH and Japanese regulations 21 CFR reviewing Writing editing submission documentation SOPs Protocols Reports. Product/Project analytical requirements evaluation budget in-house vs. out-source estimation. Upgrading of R&D laboratories to GLP/GMP level.

Ideal Companies: small start-up company

Tags for this Online Resume: methods transfer validation, phase I, II, III protocols and reports, GMP GLP, Laboratory management, hiring training budgeting, FDA ICH regulations, validation monitoring transfer, medical devices, Consulting, Document Review, Documentation, DSC, High Performance Liquid Chromatography (HPLC)