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Online Resumes with "Director Regulatory Affairs"



Regulatory Affairs Manager, New Jersey

To obtain a position as a Manager/Associate Director, Regulatory Affairs

Worldwide Director of Regulatory Affairs

Strategic Regulatory Affairs Professional with diverse and progressive experience leading growing or established companies in the pharmaceutical, biotech and medical device industry providing global strategic regulatory direction for both new and existing products, as a primary contact facilitating preparation of international regulatory documents. Advances the development of knowledge, products, people, collaboration, c...

Tags for this Online Resume: Product Registration, CMC, International Submissions, Global regulatory, BLA, INDs, Orphan Drugs, Project Management, Bilingual, International regulations

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

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, General Practice, Litigation Support, Management, Risk Management, SAN (Storage Area Network), Support

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

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

Research Regulatory Coordinator

I would like to continue my career in the regulatory field, such as Assistant Director of Regulatory Affairs or entry level regional CRA or managerial position.

Tags for this Online Resume: regulatory, coordinator, research, quality assurance, CRA, homebased

Chemist - 20 Years of Experience - Near 02467

PROFESSIONAL SUMMARY * A proven leader with a track record of accomplishments with more than fifteen years pharmaceutical industry experience in leading analytical development activities for small molecule drug development * Hands-on experience in analytical project management in drug development and regulatory submissions hands- on experience in analytical method development/validation/transfer in GMP environments expertis...

Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Quantify, Analytical Chemistry, Chemistry, Research, Research and Development, Regulatory Affairs, Applications, CMOS, Development Activities

Associate Director Regulatory Affairs

I am seeking an opportunity to continue working in Regulatory Operations focusing primarily on eCTD submissions and document management of Regulatory, Clinical, and Quality compliance documents.

Tags for this Online Resume: Regulatory Affairs, Regulatory Operations, eCTD Submissions, Clinical Trial Master Files, Quality Assurance, Document Management

Administrative Assistant - 18 Years of Experience - Near 07076

Tags for this Online Resume: AT&T, Entertainment, DMS, Dms (Data Mgmt Tool), Regulatory Affairs, CFO, Data Management, Distribution, Filing, Management

Administrative Assistant

Tags for this Online Resume: AT&T, Entertainment, DMS, Dms (Data Mgmt Tool), Regulatory Affairs, CFO, Data Management, Distribution, Filing, Management

Administrative Assistant - 18 Years of Experience - Near 07076

Ideal Companies: Tesla, Amazon, Fortune 500

Tags for this Online Resume: AT&T, Entertainment, DMS, Dms (Data Mgmt Tool), Regulatory Affairs, CFO, Data Management, Distribution, Filing, Management