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Online Resumes with "NDA"



Chief Operating Officer (Clinical and Regulatory) at CRO and Consulting company

COO or Vice President Clinical And Regulatory Affairs at small to medium Biotech/Pharma

Tags for this Online Resume: COO, Pharmaceutical , Biotechs, Clinical studies, Regulatory, NDA

Featured Profile

Senior Architect - Senior Project Manager

Seeking a position in a strategically forward thinking firm on technically demanding projects. I have a keen interest in being a leader in integrating BIM with clients and builders.

Ideal Companies: NBBJ, AECOM, ARUP, Lend Lease, HOK, M+W, DES Architects

Tags for this Online Resume: architect, project manager, BIM, senior, IPD, lab, clean room, revit

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

Scientist III - 12 years Pharmaceutical Experience

Accomplished Solid Oral Dose Manufacturing professional with over 12 years of experience in Pharmaceutical Development & Manufacturing; an expert in solid dosage form manufacturing for supporting developmental/clinical material as well as NDA batch manufacturing; well versed with cGMP and drug product quality requirements; extensive experience working with multi-disciplinary project teams and coordinating the activities of...

Tags for this Online Resume: Research Scientist , Technician , research technician , Pharmaceutical , Biotechnology , Scientist

Biochemist

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

Reviewed incoming Requests for Proposals (R.F.P.s) and Requests for Information (R.F.I.s) and prepared responses thereto. Drafted, negotiated, and revised various legal agreements with existing and prospective customers to include: software license and s

Tags for this Online Resume: contracts, non-disclosure agreements, legal, NDA's, RFP, FDA

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

Senior Clinical Project Manager - 11 years Experience - IND, start-up, successful NDA submission

Featured Profile

Operations | Program Manager with Dynamic Background in People Management and Technology - Greater Boston Area - willing to relocate

Seasoned professional in operations, program and people management with experience in technology, international sales, manufacturing, and healthcare industries. Prefer a start-up atmosphere where I can utilize my initiative and ability to independently learn and collaborate to manage projects across departments to deliver on complex contracts within tight timeframes. Would enjoy being of assistance preparing contracts, pro...

Ideal Companies: Accenture, Deloitte, First Help Financial, LED Lighting Solutions, Athenahealth Inc., Microsoft Corporation, JSI, William Raveis Real Estate Mortgage & Insurance, Winchester Hospital, Digital Lumens, Raytheon, Irobot, Schnieder Electric, MFS Investment Management, Vertex Pharmaceuticals, Cresa Boston, Arbella Insurance Group, Seaport Hotel & World Trade Center, Anna Jaques Hospital, Target, IBM, Wells Fargo, Kaiser Permanente, Bank of America, Bright Horizons Family Solutions, Infinity Pharmaceuticals

Tags for this Online Resume: Program Management, Logistics, Proposal Writing, Letters of Credit, RFQ, Supervisory Skills, Leadership, Export Control, Cross-functional Team Leadership, Interpersonal Skill, Conflict Resolution, Event Planning, Supervisory Experience, International Logistics, Logistics Management, Purchasing Processes, Purchasing Negotiation, Purchasing, Indirect Purchasing, Project Purchasing, Trade Compliance, International Sales, Project Management, Management, Compliance, Business Administration, Operations, Sales Management, Salesforce.com, International Relations, Quote Preparation, Contract Management, Microsoft Project, International Project Management, Start-ups, Facility Start-ups, Negotiation, Operations Management, Team Building, Strategic Planning, Office Management, Military Operations, Military, Army, Contract Negotiation, Customer Service, Customer Development, Systems Engineering, Security Clearance, Government Contracting, DoD, Defense, Supply Operations, Property Accountability, Material Control, Work Centers, Inventory Control Management, Valuation, HTS Coding, Commodity Classification, Imports, Risk Mitigation, Return on Investment, ROIs, Resource Management, Supply Chain Management, Accounting, Pricing, Budgeting, Facilities Management, New Technologies, Horseback Riding, Experiential, Experiential Team Building, Experiential Techniques, Leadership Training, Experiential Training, Expertise, high-energy, dynamic, fast-paced, dedicated, deployment, distribution, key enabler, support growth ambition, process advocate, implementation, traceability, opportunity generation, execution, follow-up, follow up, facilitate, facilitation, deploy, develop, collaboration, collaborate, teamwork, core teams, prioritize, define, document, documentation, evaluate, support, motivate, motivation, propose enhancements, business development, engineering, technical, delivery management, cross functional, international environment, managing multiple projects, managing multiple priorities, creative problem-solving, influence, autonomy, indepenence, global, global project, global team, global business, knowledge, services, manager, executive, supervisor, Microsoft Office, Excel, Excel Expert, Microsoft Word, Word, Power Point, Powerpoint, Access, Outlook, FileMaker Pro, Sharepoint, Zen, Costpoint, SAP, Adobe Acrobat, presentation skills, initiative, executive presence, exception written and verbal communication skills, multitask, deadline-driven, adaptability, flexibility, Superior Microsoft Office Skills, Regulations, Legal, testing, sustainable, empathetic, passionate, metrics, industry, international, budget tracking, materials management, resource managment, resource planning, communication efforts, patient advocacy, corporate communications, healthcare, patient engagement, innovative, social media

Senior Clinical & Regulatory Dtr./VP with over 20 years experience in all phases of product development.

Over 20 years of experience working in industry in biopharmaceuticals, and Class II-III medical device development. Perform hands-on management of Clinical Operations, and Regulatory Affairs. Oversee cross-functional product development teams and implement systematic project management techniques for clinical trials to ensure alignment with overall product development timelines and market release. Instill continuous quali...

Tags for this Online Resume: clinical research, project management, regualtory, medical device, cllinical trials operations, clinical development, research, IDE, 510(k), CE, PMA, BLA, NDA

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

Document Specialist - 20 years experience - Philadelphia

Tags for this Online Resume: eCTD, IND, submission readiness, NDA, Document management , ICH, FDA, EMEA, SOP