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Online Resumes with "Regulatory Filings"
Analytical chemist
Leading analytical chemist
Tags for this Online Resume: Analytical chemist, method development, validation, transfer, multiple instruments, GMP/GLP release and stability testing, CMC development process, Specification, SOP, Stability, LIMS, contract laboratories/manufacturing, Regulatory filing documents
Senior Scientist
As a research scientist I would bring my knowledge in GMP analytical testing, method development, validation, technology transfer and project management to the growth and development of your organization. I am experienced in cGMP regulations, laboratory investigations, inspections and global regulatory filings. Furthermore, I am a self-motivated, diligent, conscientious and dependable chemist with excellent analytical, co...
Tags for this Online Resume:
Chemist, Senior Scientist, Method Development, Method Validation, Auditor, Writer
Featured Profile
Featured Profile
Featured Profile
Regulatory Affairs Assistant at Medical Device Company-1 year experience-Boston
*Developed Quality Assurance and Regulatory Affairs processes, and managed databases.
*Familiarity with medical device regulations, standards: ISO 13485 and FDA guidances
*Support the submittal of product regulatory filings and maintenance with focus on US 510(k), EU technical files.
*Review design control documents including protocols and reports associated with design inputs and outputs.
*Interested in international m...
Tags for this Online Resume:
regulatory, quality, medical device, international regulatory, FDA, 510k
Featured Profile
Medical & Patient Safety
A key role as an individual and/or team contributor in medical, clinical, regulatory, and preventative activities within evolving worldwide pharmaceutical and bio-technical platforms. Cultivate strong collaborative alliances; employing diplomacy in conflicting divergence, training, and influencing consensus. Resolve obstacles to positively impact both medical and business outcomes.
Tags for this Online Resume:
Drug Safety, Pharmacovigilance, Medical Safety, Patient Safety, Medical Affairs
Drug, Biologic, Device, Combination Product R&D Director - 21 Years of Experience - Near 18938
DRUG, BIOLOGICS, DRUG/BIOLOGIC-DEVICE, R&D DIRECTOR. Directed/Created strategies, study designs, implementation, reporting, and regulatory submissions for biologics, biologic/device, and medical device projects. Led global cross-sector, cross-functional drug-device combination and drug discovery project teams across J&J companies (Pharma, MD&D, Consumer) and academia. Successful leader in matrix organizations requiring t...
Tags for this Online Resume:
New Jersey , Pennsylvania, Drug Development, Project Management, Medical Devices, Biologics
Life Scientist - 8 Years of Experience - Near 80016
I'm a genetic engineering specialist with over 7 years experience in biotech designing and executing new viral products. I have built Quality systems from the ground up and also have audited vendors on behalf of biotech companies. Experience cultivating relationships and writing grant and patent applications, as well as regulatory filings.
Tags for this Online Resume:
Denver, genetic engineeringg, molecular biology, Quality Systems, patent writing, Regulatory
Featured Profile
Clinical Research - 6 Years of Experience - Near 92649
Experienced Clinical Research Professional interested in positions within the pharmaceutical or medical device industry.
Ideal Companies: inventiv, johnson & johnson, covance, covidien, peregrine
Tags for this Online Resume:
Irvine, CCRP, regulatory affairs, clinical project manager, EDC, budgets , timelines, contracts and budgets
Featured Profile
SR. PHARMACEUTICAL QUALITY SYSTEMS & VALIDATION PROFESSIONAL
Seeking Pharmaceutical QA Position - - Full Time or Consulting Position
SR. PHARMACEUTICAL QUALITY SYSTEMS AND VALIDATION PROFESSIONAL with a broad knowledge of regulatory compliance and quality control and assurance expertise in cGMP manufacturing, operations, regulatory, supply chain management, and validation as applied to aseptic parental pharmaceutical products, tablets, APIs, and medical devices.
My experience in...
Ideal Companies: Pharmaceutical or Medical Device Companies, (Abbott; Abbvie; Hospira, Johnson & Johnson)
Tags for this Online Resume:
North Carolina, South Carolina, Florida, Texas, Missouri, Chicago, Atlanta, Associate Director of Quality Assurance, Quality Assurance Manager, Sr. Compliance QA Manager, Associate Director of Validation, Validation Director, CAPA Management, Supplier QA Manager, Director of Supplier Assurance, CMO QA Manager, Pharmaceutical QA Manager, Medical Device QA Manager, Corporate QA Auditor, CAPA Manager, API Manufacturer, Sterile Fill Pharmaceutical Manufacturer, Medical Device Manufacturer, Sr. Quality Engineer, Oklahoma, Illinois, Milwaukee WI, Validation Manager, Internal QA Auditor
Featured Profile
Featured Profile
Regulatory Affairs Assistant at Medical Device Company-1 year experience-Boston
*Developed Quality Assurance and Regulatory Affairs processes, and managed databases.
*Familiarity with medical device regulations, standards: ISO 13485 and FDA guidances
*Support the submittal of product regulatory filings and maintenance with focus on US 510(k), EU technical files.
*Review design control documents including protocols and reports associated with design inputs and outputs.
*Interested in international m...
Tags for this Online Resume:
regulatory, quality, medical device, international regulatory, FDA, 510k
Featured Profile
Medical & Patient Safety
A key role as an individual and/or team contributor in medical, clinical, regulatory, and preventative activities within evolving worldwide pharmaceutical and bio-technical platforms. Cultivate strong collaborative alliances; employing diplomacy in conflicting divergence, training, and influencing consensus. Resolve obstacles to positively impact both medical and business outcomes.
Tags for this Online Resume:
Drug Safety, Pharmacovigilance, Medical Safety, Patient Safety, Medical Affairs
Drug, Biologic, Device, Combination Product R&D Director - 21 Years of Experience - Near 18938
DRUG, BIOLOGICS, DRUG/BIOLOGIC-DEVICE, R&D DIRECTOR. Directed/Created strategies, study designs, implementation, reporting, and regulatory submissions for biologics, biologic/device, and medical device projects. Led global cross-sector, cross-functional drug-device combination and drug discovery project teams across J&J companies (Pharma, MD&D, Consumer) and academia. Successful leader in matrix organizations requiring t...
Tags for this Online Resume:
New Jersey , Pennsylvania, Drug Development, Project Management, Medical Devices, Biologics
Life Scientist - 8 Years of Experience - Near 80016
I'm a genetic engineering specialist with over 7 years experience in biotech designing and executing new viral products. I have built Quality systems from the ground up and also have audited vendors on behalf of biotech companies. Experience cultivating relationships and writing grant and patent applications, as well as regulatory filings.
Tags for this Online Resume:
Denver, genetic engineeringg, molecular biology, Quality Systems, patent writing, Regulatory
Featured Profile
Clinical Research - 6 Years of Experience - Near 92649
Experienced Clinical Research Professional interested in positions within the pharmaceutical or medical device industry.
Ideal Companies: inventiv, johnson & johnson, covance, covidien, peregrine
Tags for this Online Resume:
Irvine, CCRP, regulatory affairs, clinical project manager, EDC, budgets , timelines, contracts and budgets
Featured Profile
SR. PHARMACEUTICAL QUALITY SYSTEMS & VALIDATION PROFESSIONAL
Seeking Pharmaceutical QA Position - - Full Time or Consulting Position
SR. PHARMACEUTICAL QUALITY SYSTEMS AND VALIDATION PROFESSIONAL with a broad knowledge of regulatory compliance and quality control and assurance expertise in cGMP manufacturing, operations, regulatory, supply chain management, and validation as applied to aseptic parental pharmaceutical products, tablets, APIs, and medical devices.
My experience in...
Ideal Companies: Pharmaceutical or Medical Device Companies, (Abbott; Abbvie; Hospira, Johnson & Johnson)
Tags for this Online Resume:
North Carolina, South Carolina, Florida, Texas, Missouri, Chicago, Atlanta, Associate Director of Quality Assurance, Quality Assurance Manager, Sr. Compliance QA Manager, Associate Director of Validation, Validation Director, CAPA Management, Supplier QA Manager, Director of Supplier Assurance, CMO QA Manager, Pharmaceutical QA Manager, Medical Device QA Manager, Corporate QA Auditor, CAPA Manager, API Manufacturer, Sterile Fill Pharmaceutical Manufacturer, Medical Device Manufacturer, Sr. Quality Engineer, Oklahoma, Illinois, Milwaukee WI, Validation Manager, Internal QA Auditor
Featured Profile
Regulatory Affairs Assistant at Medical Device Company-1 year experience-Boston
*Developed Quality Assurance and Regulatory Affairs processes, and managed databases.
*Familiarity with medical device regulations, standards: ISO 13485 and FDA guidances
*Support the submittal of product regulatory filings and maintenance with focus on US 510(k), EU technical files.
*Review design control documents including protocols and reports associated with design inputs and outputs.
*Interested in international m...
Tags for this Online Resume:
regulatory, quality, medical device, international regulatory, FDA, 510k
Featured Profile
Medical & Patient Safety
A key role as an individual and/or team contributor in medical, clinical, regulatory, and preventative activities within evolving worldwide pharmaceutical and bio-technical platforms. Cultivate strong collaborative alliances; employing diplomacy in conflicting divergence, training, and influencing consensus. Resolve obstacles to positively impact both medical and business outcomes.
Tags for this Online Resume:
Drug Safety, Pharmacovigilance, Medical Safety, Patient Safety, Medical Affairs
Drug, Biologic, Device, Combination Product R&D Director - 21 Years of Experience - Near 18938
DRUG, BIOLOGICS, DRUG/BIOLOGIC-DEVICE, R&D DIRECTOR. Directed/Created strategies, study designs, implementation, reporting, and regulatory submissions for biologics, biologic/device, and medical device projects. Led global cross-sector, cross-functional drug-device combination and drug discovery project teams across J&J companies (Pharma, MD&D, Consumer) and academia. Successful leader in matrix organizations requiring t...
Tags for this Online Resume:
New Jersey , Pennsylvania, Drug Development, Project Management, Medical Devices, Biologics
Life Scientist - 8 Years of Experience - Near 80016
I'm a genetic engineering specialist with over 7 years experience in biotech designing and executing new viral products. I have built Quality systems from the ground up and also have audited vendors on behalf of biotech companies. Experience cultivating relationships and writing grant and patent applications, as well as regulatory filings.
Tags for this Online Resume:
Denver, genetic engineeringg, molecular biology, Quality Systems, patent writing, Regulatory
Featured Profile
Clinical Research - 6 Years of Experience - Near 92649
Experienced Clinical Research Professional interested in positions within the pharmaceutical or medical device industry.
Ideal Companies: inventiv, johnson & johnson, covance, covidien, peregrine
Tags for this Online Resume:
Irvine, CCRP, regulatory affairs, clinical project manager, EDC, budgets , timelines, contracts and budgets
Featured Profile
SR. PHARMACEUTICAL QUALITY SYSTEMS & VALIDATION PROFESSIONAL
Seeking Pharmaceutical QA Position - - Full Time or Consulting Position
SR. PHARMACEUTICAL QUALITY SYSTEMS AND VALIDATION PROFESSIONAL with a broad knowledge of regulatory compliance and quality control and assurance expertise in cGMP manufacturing, operations, regulatory, supply chain management, and validation as applied to aseptic parental pharmaceutical products, tablets, APIs, and medical devices.
My experience in...
Ideal Companies: Pharmaceutical or Medical Device Companies, (Abbott; Abbvie; Hospira, Johnson & Johnson)
Tags for this Online Resume:
North Carolina, South Carolina, Florida, Texas, Missouri, Chicago, Atlanta, Associate Director of Quality Assurance, Quality Assurance Manager, Sr. Compliance QA Manager, Associate Director of Validation, Validation Director, CAPA Management, Supplier QA Manager, Director of Supplier Assurance, CMO QA Manager, Pharmaceutical QA Manager, Medical Device QA Manager, Corporate QA Auditor, CAPA Manager, API Manufacturer, Sterile Fill Pharmaceutical Manufacturer, Medical Device Manufacturer, Sr. Quality Engineer, Oklahoma, Illinois, Milwaukee WI, Validation Manager, Internal QA Auditor
Regulatory Affairs Assistant at Medical Device Company-1 year experience-Boston
*Developed Quality Assurance and Regulatory Affairs processes, and managed databases.
*Familiarity with medical device regulations, standards: ISO 13485 and FDA guidances
*Support the submittal of product regulatory filings and maintenance with focus on US 510(k), EU technical files.
*Review design control documents including protocols and reports associated with design inputs and outputs.
*Interested in international m...
Tags for this Online Resume:
regulatory, quality, medical device, international regulatory, FDA, 510k
Featured Profile
Medical & Patient Safety
A key role as an individual and/or team contributor in medical, clinical, regulatory, and preventative activities within evolving worldwide pharmaceutical and bio-technical platforms. Cultivate strong collaborative alliances; employing diplomacy in conflicting divergence, training, and influencing consensus. Resolve obstacles to positively impact both medical and business outcomes.
Tags for this Online Resume:
Drug Safety, Pharmacovigilance, Medical Safety, Patient Safety, Medical Affairs
Drug, Biologic, Device, Combination Product R&D Director - 21 Years of Experience - Near 18938
DRUG, BIOLOGICS, DRUG/BIOLOGIC-DEVICE, R&D DIRECTOR. Directed/Created strategies, study designs, implementation, reporting, and regulatory submissions for biologics, biologic/device, and medical device projects. Led global cross-sector, cross-functional drug-device combination and drug discovery project teams across J&J companies (Pharma, MD&D, Consumer) and academia. Successful leader in matrix organizations requiring t...
Tags for this Online Resume:
New Jersey , Pennsylvania, Drug Development, Project Management, Medical Devices, Biologics
Life Scientist - 8 Years of Experience - Near 80016
I'm a genetic engineering specialist with over 7 years experience in biotech designing and executing new viral products. I have built Quality systems from the ground up and also have audited vendors on behalf of biotech companies. Experience cultivating relationships and writing grant and patent applications, as well as regulatory filings.
Tags for this Online Resume:
Denver, genetic engineeringg, molecular biology, Quality Systems, patent writing, Regulatory
Featured Profile
Clinical Research - 6 Years of Experience - Near 92649
Experienced Clinical Research Professional interested in positions within the pharmaceutical or medical device industry.
Ideal Companies: inventiv, johnson & johnson, covance, covidien, peregrine
Tags for this Online Resume:
Irvine, CCRP, regulatory affairs, clinical project manager, EDC, budgets , timelines, contracts and budgets
Featured Profile
SR. PHARMACEUTICAL QUALITY SYSTEMS & VALIDATION PROFESSIONAL
Seeking Pharmaceutical QA Position - - Full Time or Consulting Position
SR. PHARMACEUTICAL QUALITY SYSTEMS AND VALIDATION PROFESSIONAL with a broad knowledge of regulatory compliance and quality control and assurance expertise in cGMP manufacturing, operations, regulatory, supply chain management, and validation as applied to aseptic parental pharmaceutical products, tablets, APIs, and medical devices.
My experience in...
Ideal Companies: Pharmaceutical or Medical Device Companies, (Abbott; Abbvie; Hospira, Johnson & Johnson)
Tags for this Online Resume:
North Carolina, South Carolina, Florida, Texas, Missouri, Chicago, Atlanta, Associate Director of Quality Assurance, Quality Assurance Manager, Sr. Compliance QA Manager, Associate Director of Validation, Validation Director, CAPA Management, Supplier QA Manager, Director of Supplier Assurance, CMO QA Manager, Pharmaceutical QA Manager, Medical Device QA Manager, Corporate QA Auditor, CAPA Manager, API Manufacturer, Sterile Fill Pharmaceutical Manufacturer, Medical Device Manufacturer, Sr. Quality Engineer, Oklahoma, Illinois, Milwaukee WI, Validation Manager, Internal QA Auditor
Medical & Patient Safety
A key role as an individual and/or team contributor in medical, clinical, regulatory, and preventative activities within evolving worldwide pharmaceutical and bio-technical platforms. Cultivate strong collaborative alliances; employing diplomacy in conflicting divergence, training, and influencing consensus. Resolve obstacles to positively impact both medical and business outcomes.
Tags for this Online Resume: Drug Safety, Pharmacovigilance, Medical Safety, Patient Safety, Medical Affairs
Clinical Research - 6 Years of Experience - Near 92649
Experienced Clinical Research Professional interested in positions within the pharmaceutical or medical device industry.
Ideal Companies: inventiv, johnson & johnson, covance, covidien, peregrine
Tags for this Online Resume: Irvine, CCRP, regulatory affairs, clinical project manager, EDC, budgets , timelines, contracts and budgets
SR. PHARMACEUTICAL QUALITY SYSTEMS & VALIDATION PROFESSIONAL
Seeking Pharmaceutical QA Position - - Full Time or Consulting Position SR. PHARMACEUTICAL QUALITY SYSTEMS AND VALIDATION PROFESSIONAL with a broad knowledge of regulatory compliance and quality control and assurance expertise in cGMP manufacturing, operations, regulatory, supply chain management, and validation as applied to aseptic parental pharmaceutical products, tablets, APIs, and medical devices. My experience in...
Ideal Companies: Pharmaceutical or Medical Device Companies, (Abbott; Abbvie; Hospira, Johnson & Johnson)
Tags for this Online Resume: North Carolina, South Carolina, Florida, Texas, Missouri, Chicago, Atlanta, Associate Director of Quality Assurance, Quality Assurance Manager, Sr. Compliance QA Manager, Associate Director of Validation, Validation Director, CAPA Management, Supplier QA Manager, Director of Supplier Assurance, CMO QA Manager, Pharmaceutical QA Manager, Medical Device QA Manager, Corporate QA Auditor, CAPA Manager, API Manufacturer, Sterile Fill Pharmaceutical Manufacturer, Medical Device Manufacturer, Sr. Quality Engineer, Oklahoma, Illinois, Milwaukee WI, Validation Manager, Internal QA Auditor
