CV, Curriculum Vitae and Online Resumes Search

---

Online Resumes with "regulatory strategy"

Managing Director - 20 Years of Experience - Near 33983

Accomplished pharmaceutical and medical device regulatory affairs professional with a passion for implementing successful regulatory strategies to support organizational business development goals.

Tags for this Online Resume: Microsoft Project, Excel, Adobe Acrobat, Microsoft Word, eSubmissions, Power Point, Microsoft Visio, Publisher

Director of Quality - 15 Years of Experience - Near 77086

10+ years medical device industry in variety of areas including Regulatory strategy for domestic and international marketing. FDA submissions of 510k and EU submissions of Technical Files for CE Mark. Implementation of Quality Systems per QSR, Health Canada, ISO 13485:2012, Medical Device Directive 93/42/EEC and Active Implantable Medical Device Directive 90/285.

Tags for this Online Resume: Quality Systems, Medical Device, Regulatory Affairs, 510K submission, CE Mark, Consultant, Director, Vice President

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

Laboratory

COVER LETTER: Vanessa Nunes de Paiva, PhD Student Postdoc Research Associate Laboratory of Dean Tomas R. Guilarte, PhD Vanessa Nunes de Paiva, PhD Student Postdoc Research Associate Laboratory of Dean Tomas R. Guilarte, PhD Florida International University Departament of Enviromental & Health & Social Work Departament pf Environmental & Occupational Health 11200 SW 85th Street AHC 4, Room 340 Miami, FL 33199 Lab Phone: (305...

Tags for this Online Resume: ELISA, Email, Medical, Medical Affairs

Clinical Research

AREAS OF EXPERTISE * Clinical Trial Design * Biologics * Study Management * Medical Devices * Scientific Research * Regulatory Submissions * Program Development * KOL Relationships * Scientific Strategy * Oncology * Regulatory Strategy * Cardiovascular * Investigator Recruitment * Gastrointestinal * International Clinical Trials * Regenerative Medicine * Data Analysis * Surgery

Tags for this Online Resume: Clinical Research, Research, Pathway, Protocol, Regulatory Affairs, Infrastructure, Pharmaceutical, Publications, Selenium, Venture Capital, oncology, phase, clinical, gcp, protocol, trial, pharmaceutical, ich

CEO of Quality/Regulatory Affairs- 19 Years of Experience - New York

SUMMARY Senior Executive with combined technical, regulatory strategy, project management and business experience to build businesses and relationships to deliver new products to market. Over 20 years of experience in medical device, pharmaceutical, biologics, and diagnostic development, including In-Vitro Diagnostic, with market leaders such as Johnson & Johnson, Watson Pharmaceuticals and Mela Sciences. Led worldwide regu...

Tags for this Online Resume: Management, Manufacturing, Product Development, Risk Management, Process Engineering, Engineering, Quality, Quality Assurance, Quality Control, Regulatory, Strategy, Clinical Development, Pharmaceutical, Medical Device, Green Belt, PnL

Manager - 10 Years of Experience - Near 60564

SUMMARY Information Technology Manager supporting mortgage collection services leading development of applications for regulatory and strategy based requirements. Skilled at balancing multiple projects ensuring stakeholder satisfaction with timely deliverables. Highly effective at communicating with the end user and translating technical requirements. Early finance roles created credibility and understanding of stakeholder ...

Tags for this Online Resume: Customer Service, Underwriting, Capacity Planning, Due Diligence, Planning, Statistics, System Testing, Test, Collection, SAS, it jobs, html

Regulatory Affairs Specialist

I am Yashica, working as a Regulatory Affairs Specialist and open for new job opportunities. I possess Masters Degree in Regulatory Affairs and have a working experience of Two Years (Plus a research Experience in Regulatory and Clinical area for two years). I am able to work in a Matrix and fast paced environment where one needs to prioritize the tasks and complete in a timely manner. I have handled projects independen...

Tags for this Online Resume: Regulatory Affairs, CMC, Labeling, Submissions, Regulatory Strategy , Clinical

Quality Assurance Director - 18 Years of Experience - Near 55379

Summary of qualifications Global Quality System and Regulatory Compliance Experience in Regulated Environments (Medical Device/Pharmaceutical/Food/In-Vitro Diagnostics) including implementation of design controls * Global Regulatory and Quality Compliance (creating processes for Field Actions/point of contact for all recalls with the FDA/806 and monthly reporting) * Regulatory partnering with FDA and International Agencies ...

Tags for this Online Resume: Documentation, Infrastructure, Management, Program Management, Budget Preparation, Budgeting, Development Activities, P&L, Product Development, Project Management

Senior Counsel/Compliance Counsel Mortgage Industry - Compliance Counsel/Financial Services - 20+ Years Experience

Stripped down to its core, my "Career Objective" is to maintain - through those policies and procedures I have created - a clear understanding that upholding a viable "culture of regulatory compliance" does NOT automatically equate to a loss of business or operational interference.

Tags for this Online Resume: Compliance, Consulting, Litigation, Financial Industry, counsel, Complaints, general counsel, chief compliance officer, Policies and Procedures, Financial, Senior Counsel, strategist, regulatory compliance, Dodd-Frank, Privacy/Reg B