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Online Resumes with "regulatory affairs "



Clinical Research

Pamela's objective is to acquire a home-based/telecommute position within the clinical research field. Areas of primary interests are line manager, in-house CRA or regulatory affairs; however, open to other options. Her skill sets and work ethic are highly applicable the the clinical research arena

Tags for this Online Resume: Query, Audit, Data Queries, Email, Employee Relations, Human Resources, Medical, clinical, phase iii, phase iv, phase ii, phase i, research, clinical trials, pharmaceutical, cro, regulatory, resourcing, study lead, Sr. CRA, In-house CRA, Line Manager, Clinical Site Manager, devices, clinical coordinator, psychiatry, occupational therapy, job placement coordinator, job skill evaluator, customer service, bid defense, banking, sales, trainer, supervisor

Clinical Research - 20 Years of Experience - Near 46311

I desire the opportunity to leverage my skills and expertise in the healthcare industry in leadership, clinical research, regulatory affairs and quality assurance.

Tags for this Online Resume: Chicago, clinical research, document management, regulatory, regulatory , project management, government programs, MicroSoft, Cancer, Administrative Assistant

Chief IP Officer - 20 Years of Experience - Near 97140

Summary: Admitted to the California Bar and USPTO * Law firm experience: Oblon Spivak - Associate (San Jose, CA) Arter & Hadden - Partner (San Francisco, CA) * In-house experience: (a) Chief IP Officer - SAP (b) CEO, Chief Patent Counsel and Director of Regulatory Affairs - Corinthian Ophthalmic (c) Head of IP Due Diligence, Licensing, and Trademarks - National Semiconductor (d) VP Business Development, GC - Exponential Tec...

Tags for this Online Resume: Regulatory Affairs, Litigation, Business Management, Electronics, Litigation Support, Management, Risk Management

Clinical Regulatory Affairs - 20 Years of Experience - Near 07054

Tags for this Online Resume: Its, Management, Risk Management, Leadership, Planning, Publications, Medical, Documentation, Microsoft Excel, Microsoft Internet Explorer

Quality Assurance Director - 20 Years of Experience - Near 92131

Summary Extensive strategic management development, deployment and execution supporting C-level, SVP and Sr. Management leading regulatory action remediation projects, coaching sponsors, key stakeholders and teams through containment, control, and compliance driving sustainability goals for Life Science companies in Biotechnology, Pharmaceuticals, Medical Device and Combination Products, addressing process improvement initi...

Tags for this Online Resume: Director Quality Assurance, Director Regulatory Affairs, Senior Project Manager, Director PMO, ISO, Software, Software Development, Quality Compliance, Director QARA

Regulatory Affairs Specialist - 16 Years of Experience - Near 19464

An accomplished records and information management specialist with proven skill set including 16 years’ experience within records retention and information management. Focus on health authority audit preparedness, compliance, security, and lifecycle management requirements of key company proprietary media encompassing all GXP documentation. Actively liaise with internal areas and external groups including CMOs and CROs to ...

Tags for this Online Resume: Filing, Management, Quality, Quality Assurance, Quality Control, Retention, Document Management, Documentation, Information Technology, Records and Information Management, Regulatory, Operations, Record Coordinator, Compliance, Regulatory Operations

Featured Profile

Director of Quality & Regulatory- 22 Years of Experience - Near 45142

Summary Twenty-two years in the Medical Device Manufacturing Field, including 16 years of Director level experience in Quality Managements Systems, Regulatory Affairs and Quality Assurance/Quality Control Activities. Knowledge and professional experience in the following areas: Quality, Engineering and Manufacturing Implemented practical oversight of the following: * ISO13485 * ISO9001 * 21CFR820 (FDA) * ISO14971 Risk Manag...

Ideal Companies: A company with suability, growth and development of their employees.

Tags for this Online Resume: Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory

Federal Government - 16 Years of Experience - Near 93012

SUMMARY OF QUALIFICATIONS * 16+ years of public/private sector experience aimed at reducing regulatory burdens, limiting regulatory and legislative exposure and spearheading revenue-generating initiatives * Strategically positioned CEO, executives and franchisees in public sphere to develop strong relations with elected representatives and key community constituencies to advance franchisor/franchisee interests * Success in ...

Ideal Companies: Tesla, Boeing, FCA

Tags for this Online Resume: Compensation, Government, Media Relations, Bilingual, Commissions, Communications, Management, Public Relations, Video, FACETS, Government Affairs, SVP, VP, Global Affairs, Regulatory Affairs

Controller - 20 Years of Experience - Near 92056

PROFILE * Summary: Expertise in managing high-growth and turn-around situations. Operations oriented. Strategic thinker with hands on, roll up the sleeves and detailed oriented work ethic. Successful in partnering with cross functional management. Stable and Progressive Career. Managed multi-site multi-country operations. * Industry: Manufacturing, Environmental, Industrial and Commercial Service, Construction, Government C...

Tags for this Online Resume: Financial, Accounting, Services, Business Development, Consulting, Process Improvement, Transportation, finance, gaap, excel, controller, accountant, accounting

Clinical Regulatory Affairs - 1 Years of Experience - Near 02215

PROFESSIONAL SUMMARY I am seeking challenging and interesting opportunities in the areas of Regulatory Affairs, Quality Assurance, Drug Safety and Clinical Research. I possess strong written and communication skills with minute attention to detail. I am a dedicated team leader who can be relied upon to help achieve targets.

Tags for this Online Resume: Medical, Adobe, Clinical Research, Data Entry, Documentation, ICH, Integrated Development Environments, ISO, Microsoft, Microsoft Excel, clinical, protocol, pharmaceutical, trial, phase

Clinical Regulatory Affairs - 2 Years of Experience - Near 02215

PROFESSIONAL SUMMARY: A Regulatory Project Manager with 2+ years of managing IND/NDA/BLA review processes and 1+ years of cGMPs experience in pharmaceutical industry. Deadline-driven and highly reliable professional, successfully managing over 300 applicants' submissions in IND, NDA, BLA, and BSE as well as participating in 4 cGMPs sponsors' inspections (Japan and Taiwan) and 1 FDA inspection at manufacturing plants. Great ...

Tags for this Online Resume: Compliance, Pharmaceutical, Project Management, Regulatory affairs, CMC, NDA, IND, BLA, cGMP, GCP, ICH

Clinical Regulatory Affairs - 6 Years of Experience - Near 27712

Tags for this Online Resume: Management, ArcGIS, Clinical Research, Communication Skills, Custody, Family Law, Geographic Information System, Litigation, Microsoft, Microsoft Access