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Online Resumes with "REGULATORY "
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
I bring over 20 years of management experience in the coordinating, implantation and leadership of Safety management that i believe is second to none. I am a high energy manager successful in building and motivating dynamic Safety teams. I've cultivated c
I was responsible for overseeing the development and implementation of both companies' safety programs and ensuring safety compliance. I provided technical and non-technical advice as a subject matter expert with safety and health regulations, polices, standards and program in order to determine and ensure regulatory compliance. I worked both with field personnel along with office staff to ensure alignment with State and Fe...
Senior, Staff accountant, Financial Analyst, controller, auditor
I am an experienced accountant with manufacturing, banking, oil and gas exploration, military logistics, and government regulatory experience who is innovative, flexible, adaptive, creative, team builder, and up to date in information technology trends and applications. which can greatly contribute to a company's goals and bottom-line
Tags for this Online Resume: Finance, Accounting, Budgeting, Audit, compliance, Controller
Experienced Business and Finance Analyst
I seek work in an organization that will allow me to fully utilize my creativity and skills to make an impact on profitability as well as promote the well-being of the next generation.
Ideal Companies: Canadian Solar, Sunpower, The Learning Company, Inspiration Software, Inc.
Tags for this Online Resume: Data Mining, Competitive Market Analysis, Process Improvements, Forecasting Abilities, Ad Hoc Analysis, Communication, Budgeting and Planning, Manufacturing Planning, Logistics Management, Customer Relationship Management
Senior Air Quality Engineer/Energy Specialty
Interesting and challenging position with a prominent company. Environmental compliance responsibility, especially air quality regulations.
Tags for this Online Resume: Environmental, Compliance, Air, Regulatory, Engineering, Modeling
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...
Senior Human Resources Manager - 15+ years Experience - Global
I successfully direct and align human resources initiatives with critical business needs, strategy and objectives directly impacting the organizations performance. My greenbelt and project management skills establish and set direction for organizational structure, workforce planning, talent management, change management, performance and succession planning. Highly skilled in regulatory compliance and employment law, I lea...
Ideal Companies: Open to any Industry
Tags for this Online Resume: Global HR, HR Metrics & Analysis, Project Management, Employee Relations & Advocate, Trusted Advisor, Labor Relations, Investigations, Performance Management, Best Practices, Six Sigma Green Belt , Total Rewards, Change Management, Leadership Training & Development , Organization Design, Workforce Planning, Corporate Services, Talent-Succession Planning, Compensation & Benefits
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
Senior Auditor / Senior Client Accounts Manager / Senior Portfolio Manager
Personal statement: Pieter van Zyl A Qualified certified accountant, with international financial services experience, holding South African and British citizenship. Career commenced in Commerce, qualified as a public accountant with further extended knowledge in the Financial service Industry (Channel Islands, Isle of Man). I have worked within Client Accounting management and Management positions at different levels whil...
Tags for this Online Resume: Financial Accountant, Auditing , Tax and portfolio management, Certified Accountant practice, Regulatory Reporting , Funds professional
Sales marketing business manager
Agronomy, Technical Chemical Formulation, Sale, Marketing, Agricultural Chemical, Management, strategic planning, Market research, Six Sigma,
Ideal Companies: Davey Tree Resources, DuPont, basf, Monsanto, NuFarm, Syngenta, Aventus, Bayer
Tags for this Online Resume: Budgeting, Buiness Management , Business Plan Developement, Agricultiure Chemical , Fianance, Strategic Planning, Sales, Market Research, six Sigma, Outlook@, PowerPoint@, Human Resources, Advertising, communications
Strategic Communications Executive - 15 years Experience - Vice President - Investor Relations, Chief Governance Officer
I am a dynamic executive with extensive knowledge of strategic communications, including investor relations, corporate governance, and regulatory compliance.
Tags for this Online Resume: • Investor Media Relations, Corporate Communications , • Corporate Governance, • Regulatory Compliance, Strategic Planning, • Ethics/Whistleblower
Physician's Practice Administrator
Self-starter, detail oriented professional with over 20 years experience in the healthcare billing and coding industry. Efficient leader with demonstrated ability to manage staff and educate physicians in compliance with regulatory standards and procedures leading to increased revenues and successful audits.
Tags for this Online Resume: Administrator, Registered Nurse, Medical Billing, Compliance Officer, Educator, Manager
