CV, Curriculum Vitae and Online Resumes Search

---

Online Resumes with "BLA"

Sr. Director/Director Clinical Quality Assurance and Compliance

Over 19 years of Regulatory / Clinical Quality Assurance & Compliance / Auditing experience. Maintain an excellent knowledge base of all applicable Guidelines, FDA Regulations as well as best practices. I have prior interaction with the FDA, and EMEA/MHRA authorities, leading to successful outcomes. I am considered to be a strategic leader and planner effective in a team environment and customer service focused, with exc...

Tags for this Online Resume: Clinical Quality Assurance, Compliance, Auditor, GCP, Quality Systems, Director

Scientist or Manager

Biological Products, Quality, Bioanalytics, Vaccine, Cell line, biochemistry, manufacture, pilot plant, cell culture, fermentation, immunoassay, virus, influenza, nutrition, public health, cGMP, FDA, IND, CMC, BLA, clinical trial, pre-clinical, formulation, R&D

Tags for this Online Resume: biological, vaccine, quality, assay, manufacture, regulation

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

Regulatory Affairs Professional

I'm a clinical regulatory affairs professional with experience in taking medical device products to market in different countries. My experience includes all phases, including study design, budgeting and timeline development, medical writing (e.g., clinical protocol, IND, IDE, etc), clinical study initiation and oversight, data management, premarket notifications (e.g., 510(k), BLA, etc), clinical study reports, and direct ...

Tags for this Online Resume: FDA, ISO, submissions, 510(k), BLA, regulatory strategy, medical writing, management, medical devices

Creative Writer and copywriter with 10 Years of Experience - Portland, Oregon

Drug, Biologic, Device, Combination Product R&D Director - 21 Years of Experience - Near 18938

DRUG, BIOLOGICS, DRUG/BIOLOGIC-DEVICE, R&D DIRECTOR. Directed/Created strategies, study designs, implementation, reporting, and regulatory submissions for biologics, biologic/device, and medical device projects. Led global cross-sector, cross-functional drug-device combination and drug discovery project teams across J&J companies (Pharma, MD&D, Consumer) and academia. Successful leader in matrix organizations requiring t...

Tags for this Online Resume: New Jersey , Pennsylvania, Drug Development, Project Management, Medical Devices, Biologics

Worldwide Director of Regulatory Affairs

Strategic Regulatory Affairs Professional with diverse and progressive experience leading growing or established companies in the pharmaceutical, biotech and medical device industry providing global strategic regulatory direction for both new and existing products, as a primary contact facilitating preparation of international regulatory documents. Advances the development of knowledge, products, people, collaboration, c...

Tags for this Online Resume: Product Registration, CMC, International Submissions, Global regulatory, BLA, INDs, Orphan Drugs, Project Management, Bilingual, International regulations

Global Drug Safety professional

Drug safety, medical monitoring professional with 7 years in drug safety and over 15 years in clinical research, pursuing challenging drug safety lead position where my education, experience and knowledge can be implemented and utilized accordingly

Tags for this Online Resume: NJ, Drug Safety Director/Medical Monitor, Signal detection, causality relatedmess assesment and determination, SAE reports and line listings, RMP, , coding review and approval, approve, protocol, IB, DSUR, PSUR, SOP's, etc, Assist with BLA, IND, MAA in EMEA , DSMB, KOL, Site and vendor selection.

Medical Office Manager - 1 Years of Experience - Near 02120

Seeking a position to utilize my skills and abilities in the corporate sector that offers professional growth which is being resourceful, innovative and flexible. Knowledge of ICH guidelines and safety reporting requirements, good manufacturing practices (GMP), good laboratory practice (GLP) and good clinical practices (GCP). Understanding of FDA regulations and knowledge of IND, NDA, BLA, Drug Master File (DMF), 510(k) and...

Tags for this Online Resume: Boston, GLP, GCP, FDA Regulations, Medical Device

Landscape Architect - 15 Years of Experience - Near 84094

I have been working in the Landscape Architecture and Construction industry for nineteen years. Fourteen of those have been as a licensed individual. I graduated with a BLA from

Tags for this Online Resume: Urban Planner, Planner, Architect, Landscape, Autodesk AutoCAD, Construction, Engineering, Landscape Architect, City planner

Microbiologist - 20 Years of Experience - Near 45066

Summary of Experience William H, Fleming, III, PhD has thirty five plus years in the plasma, biopharmaceutical, medical device, contract manufacturing and hospital based clinical industries. He specializes in operations management and quality systems for active pharmaceutical ingredients, finished plasma derived drug products, medical devices, small molecule sustained release microsphere based drug products, biological prod...

Tags for this Online Resume: Regulatory Compliance, Regulatory Affairs, Regulatory Compliance Auditing, Analytical Chemistry, Method Validation, Process Validation, Microbiology, Standard Operating Procedures, CMC BLA 510K, Policies and Procedures

Clinical Research - 10 Years of Experience - Near 18901

Summary: * Several years of clinical experience in the industry with excellent knowledge of drug development in different therapeutic areas including oncology, immunology, vaccines, metabolism and biosimilars. Solid clinical practice experience. * Many years of Drug Safety, pharmacovigilance, risk management and epidemiology experience * Experience interfacing with health authorities (worldwide), institutional review boards...

Tags for this Online Resume: Oncology, Protocol, Regulatory Affairs, Risk Assessment, Management, Risk Management, Risk Management Activities, Complaints, Documentation, Hematology, Medical Affairs, Clinical Development