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Online Resumes with "regulatory affairs"
Agricultural Technician
Trainee Executive Regulatory Affairs
Agricultural Technician
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
Mexico
Able to expedite the documents required by Latin America BoH. Knowledge of the different sections (CTD) that have direct impact on the product. Knowledge of Latin America regulations relative to pharmaceutical and nutritional products. Capable of preparing documents for registration, variations and product renewals.. Knowledge of Good Documentation Practices. Able to expedite legal documents that make up a dossier. Evaluati...
Clinical Affairs Director - 15 years experience - San Diego
An experienced senior manager seeking a biotechnology leadership position in a pharmaceutical, medical device or in vitro diagnostics company that values innovative solutions for managing diseases that have unmet medical needs.
Ideal Companies: Pfizer, Novartis, Illumina, Hologic, Genoptics, Edwards Lifesciences, Metametrics, Roche, Genentech, Thermo-Fisher Scientific, Avanir, Celgene, Pharmaceuticals, Zogenics, Arena Pharmaceuticals, Ignyta, Endologix, ISIS Pharmaceuticals
Tags for this Online Resume: clinical, affairs, scientific, trials, innovative, management, summary, documents, submission, regulatory, 510(k), ISE, ISS, PK/PD, communicating, monitoring, tactical, strategic, literature, direct, vision, Lead, Director, documentation, resources, execution, consensus, effectiveness, safety, CRA, IVD, medical, device, pharmaceutical, presentation, manuscript, abstract, poster, programs, leadership, career, development, appraisals, optimize, goals, objectives, internal, external, research, investigator, stakeholders, customers, prioritize, product, support, milestones, Microsoft, Word, Excel, statistics, data, analysis, Powerpoint, publication, growth, deliverables, diagnostic, prognostic, treatment, competitive, proven, ability, capable, assess, strategy, feasibility, methodology, design, develop, produce, recommend, recommendation, therapeutic, supervision, review, performance, appraisal, application, indication, company, collaborate, expert, justification, senior, executive, assessment, experienced, marketing, pre-market, pre-IDE, protocol, communication, utility, pharmacology, service, deliver, delivery, drug, metabolism, absorption, excretion, train, training, mentor, mentoring, CRO, reimbursement, XLSTAT, Prism, relationship, contract, consult, consultant, ownership, responsibility, authority, delegate, trends, direction, in-vitro, commercialize, commercialization, approval, clearance, patient, oncology, cancer, metabolic, cardiovascular, kidney, disease, health, outcomes, safe, effective, toxicity, novel, unique, unmet, need, advisors, advisory, committee, IRB, ethical, justified, supportive, care, associate
Director, Regulatory Affairs for medical device products
To continue working with FDA personnel and Quality personnel in a medical device company to get products developed according to FDA and company requirements to meet the product requirements of the IVD industry
Tags for this Online Resume: Director/VPQuality Assurance, Director/VP Regulatory Affairs
Biochemist
Tags for this Online Resume: Regulatory Affairs , FDA EMA, NDA MAA, Compliance , Clinical - CMC, Leadership, Experienced IND CTA, Proficient- Pragmatic , Innovation
Clinical Research
Tags for this Online Resume: Clinical Research, Regulatory Affairs, Data Management, Lab Technician
Toxicologist/Preclinical Safety/Regulatory Affairs
I am a Board-Certified toxicologist with extensive regulatory affairs experience. I have been in the field 20+ years. I have authored regulatory submissions, designed toxicology programs, and conducted due diligences across therapeutic areas.
Projector/Administrative Coordinator - Compliance, Policies, 4 years experience - Atlanta, GA
I am a project/administrative coordinator with 4 years experience in hospital administration and close to 15 years of overall Healthcare experience including document specialist and medical transcriptionist.
Tags for this Online Resume: Project Coordinator, Compliance, Regulatory, Administrative Coordinator, Poilicies & Procedures, Safety Coordinator, Insurance, Document Specialist
Regulatory Affairs or Industrial Hygiene
Looking for a job as a regulatory affairs manager or industrial hygienist.
Tags for this Online Resume: Writing, Translating reports, Putting together Powerpoint presentations, Working with Excel, Budgeting, Industrial Hygiene
