CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "CTD"

Director of Quality - 20 Years of Experience - Near 91325

To utilize my Education, professional experience and expertise on pharmaceuticals, Nutraceuticals, and Personal care products to improve productivity and reduce production cost by managing rework, waste control and proper schedule to finish the assign job on time. Extensive practical experience in formulation, Development, Optimization, Scale-up, Validation and tech-transfer activities for the following: *Generic pharmaceu...

Tags for this Online Resume: Director Research and development and production, cGMP, GMP, SOP, CMC, QBD, Quality by Design, scale up, validation, Monitoring, DMF, CTD, drug master file, Injection, parenterals, Lyphilization, Tablets, Capsule, Cosmetics, cream, lotion, gels, softgel, powder for drinks, Liposoms, ethosoms, Sustain Release tablet, control release tablet, Granulation, compression, Coating, Formulation, production, Medical device, Drug loading, drug delivery, Autoclave, ETO gas sterilization, steam sterilization, Heat sterilization, Depyrogen sterilization, Large volume parenteral, small volume parenteral, ophalmic ointment,eye drops,

Quality Assurance Director - 4 Years of Experience - Near 08736

Accomplishments: * Led a group of 6 employees in a 24-person firm * Led a group of employees and consultants to file Icotinib IND to FDA for NSCLC * Directly handled post - IND interactions/questions with FDA * Lined up Accenture to handle eCTD publishing and submissions * Led a group to assemble and file Briefing Packages to UK, Canada, Australia and Singapore Regulatory Authorities set up and presented face-to-face meetin...

Tags for this Online Resume: Regulatory Affairs, Advertising, Business Plan, Filing, Assessments, Business Development, Chemistry, Consulting, Due Diligence, Integrate

Architect - 11 Years of Experience - Near 08817

PROFESSIONAL SUMMARY * Experienced Selenium Automation Testing. * Good experience in Web UI automation testing with Selenium Web Driver, Java, Junit, TestNG frame works. * Proven experience in using Java and CSharp for Automation * Experienced in setup Project Setup in Eclipse * Experienced in suggest and creating new Framework from scratch or can adopt existing frameworks as well. * Experienced in working on Data Driven fr...

Tags for this Online Resume: Documentum, Documentum (Wkflow Sw), Integrate, Test, Test Plan, Java Programming Language, Javascript, Selenium, Sharepoint Technologies, Test Script

Clinical Regulatory Affairs - 13 Years of Experience - Near 45208

SUMMARY Over 15 years industrial experience, with skills in pharmaceutical and beauty care industries, including expertise in areas such as FDA electronic product license applications, European regulatory affairs, consumer and product testing, and manufacturing compliance. I am a self-motivated creative team player, processing excellent interpersonal skills, strong leadership, communication and organizational abilities seek...

Tags for this Online Resume: Scheduling, Compliance, Mutual Recognition, Manufacturing, Procurement, Project Management, Project Manager, Regulatory Affairs, Management, Project Coordinator, European Experience, eCTD Publishing

Contract Medical Writer - 10 Years of Experience

Biomedical Ph.D. from Duke University with almost 10 years of diverse medical writing (regulatory and publications) and pharmaceutical industry experience supporting multiple phase I, II, and III trials. Seeking contract medical writing roles in a pharma/biotech setting.

Tags for this Online Resume: Clinical Study Reports, Medical Writer, Pharmaceutical, clinical trial, CTD/NDA, protocol, regulatory, publications

Clinical Regulatory Affairs - 5 Years of Experience

Profile Regulatory Affairs Specialist with more than five years of experience in the pharmaceutical and biotechnology industries, implementing global regulatory filing strategies. Education in biotechnical engineering with deep knowledge and practical skills in managing the submission process from start to end, monitoring and tracking information, communicating with colleagues, managers and subject experts for efficiency an...

Tags for this Online Resume: Manufacturing, Packaging, Pharmaceutical, Regulatory Affairs, Biotechnical, Filing, Management, Medical, Medical Devices, Microsoft Office

Clinical Regulatory Affairs - 13 Years of Experience - Near 19711

My background includes six years experience as a Project Manager for Regulatory Global submissions, as well as Life Cycle Management of Regulatory documents. As a Project Manager within the Submission Management Group, I provided expertise on global submission compilation and published electronic submissions compiled in RSS Application (eCTD) in accordance with Health Authority guidelines and departmental standards.

Tags for this Online Resume: Newark, DE, eCTD, RSS Application, Regulatory Publisher, Regulatory Submissions, Document Management, Legal, Management, Project Management, Publishing, Quality Assurance, Test, eCTDXpress

Biochemist - 18 Years of Experience - Near 21224

QUALIFICATIONS SUMMARY * cGMP quality management experience [ QA/QC and RA]. QA experience with quality management systems (QMS) and documentation, batch record reviews, annual product reviews, SOP drafting, review and approve, investigate deviation, change and document control. Established key performance indicators (KPIs), quality by design (QbD) process analytical technology (PAT) and Quality metrics. Experienced with de...

Tags for this Online Resume: Reviews, Chemistry, CMOS, Compliance, Documentation, Drafting, Product Development, Security, Systems Development, High Performance Liquid Chromatography (HPLC), pharmaceutical

Automotive Engineer - 20 Years of Experience - Near 60134

Established * Provided technical direction and communication between Bosch Germany and the Eaton Marketing Team for all applications of Heavy Duty ABS. * Performed validation/certification testing, provided customer interface, and technical direction to the Joint Venture on all Trailer ABS Systems. WILLIAM A . MARESKO CONTACT E XPERIENCE, CTD. 107 Grant Avenue Senior Applications Engineer, Robert Bosch Corporation, Ctd. ins...

Tags for this Online Resume: Aerospace, Fabrication, Integrate, ABS, Applications, Automotive, Test, Control Systems, Diagnostics, System engineering

Clinical Pharmacovigilance/Drug Safety - 20 Years of Experience - Near 95117

CAREER SUMMARY * Senior, seasoned pharmaceutical R&D professional with strong administrative, strategic & scientific planning, and coordination/execution skills, gained through 27 years of industrial experience in leading CMC technical development function (Pharmaceutics & Analytical), and leading global development & regulatory filings for NMEs (small molecule and biologics / mAb), and 505 (b) (2) products strong expertise...

Tags for this Online Resume: CMC, Product Development, Regulatory Affairs, Good Manufacturing Practices, Management, Project Management, Technical Lead, DP, Product Development, Supply Chain, Technical Operations

Team Leader - 10 Years of Experience - Near 08872

Tags for this Online Resume: agile, it jobs, java, software, html, sql, DevTest, JMeter, BDD, CTD, Performance Testing, Manual Testing