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Online Resumes with "Approvals"
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...
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
Human Resources Administrator/Manager
Someone who can work independently and perform all of the tasks of the Human Resources field, payroll, hiring, benefits administration, as well as preparing detailed spreadsheets for tracking productivity, sales, etc. Very detail oriented, resourceful, creative, great computer skills, as well as communication and people skills.
Ideal Companies: Small company where people are people and not just a number
Tags for this Online Resume: HR Manager, HR Administrator, Office Manager, Accounting Administrator, Payroll Administrator
Team Building Engineering Manager
Experienced Engineering Manager that has developed young Engineers and led engineering teams from concept through production. Looking to bring my experience to a company that needs a professional that will develop a diverse engineering team and take it to the next level.
Ideal Companies: Hi-Tech Fortune 500 Companies
Tags for this Online Resume: Mechanical Engineering, Root Cause Analysis, Part Fabrication, Mechanical Inspection, Metrology, GD, ASTM Y14.5-2009, Environmental Testing, Product Development, Quality Tracking, Process Improvement, Cost Management, FMEA, DVP, SolidWorks, AutoCAD, Autodesk Inventor, Epicor, Microsoft Office, Market Research, Statement of Work, Document Control, CNC Machining, CNC Inspection, Faro, Mitutoyo, Enterprise PDM, RFQ, RFI, Change Orders, HVAC, NVH, Estimating, Synthesis Engineer, Machine Shop, Composites
project and permit coordinator, assistant project manager, public works and zoning inspector
years of working with government agencies, plans reviewer, inspections for public works department. i have strong knowledge for moving project through to final approval up to certificate of completion and occupational license. Very strong communication , team player, time management and problems resolving skills.
Tags for this Online Resume: california, CONSTRUCTION project coordinator, ASSISTANT PROJECT MANAGER, project logistic, expeditor , plan reviewer, inspector
Human Resources Manager
• A very resourceful, creative, extremely organized, team oriented and accountable individual with excellent interpersonal communication skills to interface with multi levels of the organization and customers in a fast-paced union and union-free environment.
Environmental Scientist - 5 years Experience - Phoenix, AZ
A dynamic environmental professional with a Master of Science in Technology degree, with extensive experience in environmental management, has the ability to integrate clients, administrators and agencies to set and achieve objectives. Provides excellent support to executive management.
Tags for this Online Resume: RCRA, EPA, Sustainability, DOT, HAZWOPER , Microsoft Office
Product Development and Project Manager
Experienced in product development, with strong project management skills.
Ideal Companies: Vince, David Yurman, Amazon.com, Gorjana, Rag and Bone, Alice and Olivia
15 years land Planner all aspects of subdivision design including Client representation during the longpublic approval process
BS in civil Engineering + MS (structural)
Plant Shift Manager
At this point I want to make the next career move to a company that I can grow with and retire from. While with this company I want to add value to the company through my ability and education to train staff, set goals, plan for future company development and the development of the employees in my charge. It is my strong belief that a company is only as strong as its weakest link. For that reason I belief it is imperative t...
Ideal Companies: Beverage production and packaging
Tags for this Online Resume: Management, People person, Intrapersonal, Quality control, Change management, Project planning, Strategic planning, Team Building, Team management, Personal development
Business Systems Analyst well versed in various areas including, servicing operations, compliance and risk, implementations, documentation, training policies and procedures. Served as program and project manager for large call center environments
Results-driven professional specializing in the Financial Services sector eager to contribute expertise in Business Development, Operations Management, Risk and Compliance toward collaborating with a progressive organization in optimizing bottom-line performance.
Ideal Companies: Fortune 500 companies and large corporations
Tags for this Online Resume: Problem Solver, Process Improvement, Loss Mitigation , Change Management, Quality Control , SDLC methodigies, Strong written and verbal skills, Systems Analyst, Business Analyst, Audits, Benifit Analyst, Risk Management, Internal Controls, Scheduling, QC/QA, Strategic Planning, Team Leadership / Motivation, Training / Development, QA Testing, Policy Development, Talent Management, Employee Engagement, Negotiations Policy Development, Performance Management, Needs Assessment, Customer Service, Project Management, Techincal Writing, Business Control Testing, QA / Control Management
