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Online Resumes with "Regulatory submissions"
Pharmacist with 16 years of experience in various roles ranging from clinical setting to regulatory activities
Ideal Companies: pharmaceutical
Tags for this Online Resume: pharmacovigilance, regulatory operations, regulatory submissions, drug safety, regulatory affairs
Tags for this Online Resume: research coordinator, study coordinator
Regulatory Affairs Professional
Accomplished Regulatory Analyst with expertise in all stages of drug lifecycle management and experience in strategy implementation and submission management, eager to contribute to the success of a progressive organization. Proven success in achieving and exceeding company goals and objectives in all aspects of day-to-day regulatory affairs and quality assurance initiatives. Adept at recognizing and analyzing several the...
Clinical Research Associate - 5 yearsexperience - Regulator Affairs
I am currently looking for an appropriate job opening in a Research Institute. I have five years experience as a Clinical Research Associate (as Regulatory Officer and Medical Writer). I had been working with reputed pharmaceutical companies in India. I have led a team of Medical writers and as a part of them, I have written Clinical and Pre-clinical overviews on more than 100 molecules for regulatory dossier submission ...
Tags for this Online Resume: Protocol Development, Clinical study report, Clinical study audit and monitoring, Regulatory dossier submission, RMP, PSUR, Leaflet, Regulatory queries
Sr. Clinical research Associate/ Director of clinical research
Can undertake most of the tasks and works independently. Very much focussed on the timelines and quite goal tending. Willing to help others in their prioritized tasks. Excellent planning, design and implementation. Highly experienced in writing reports and data analyses.
Ideal Companies: Pharmaceutical industries, Biotech companies, Research institutes, hospitals and for profit mid to large companies.
Tags for this Online Resume: Director of clinical research, Manager of drug safety, Senior clinical research associate, Regional clinical research associate
Manager Preclinical Toxicology&Pharmacology
Biological Science Professional with extensive hands-on expertise developing strategies, conducting toxicity and safety pharmacology studies, and interpreting scientific reports to support human trials and regulatory submissions. Consistent history developing highly successful methods for isolating freshly prepared hepatocytes from a wide variety of species, including human. Broad experience developing, implementing and pe...
Tags for this Online Resume: toxicology, metabolism , pharmacokinetics, ADME, FilemakerPro, CRO
Tags for this Online Resume: Regulatory Submissions, Clinical Research Associate, Regulatory Compliance, Regulatory Affairs, clinical research coordinator
Medical Writer - 10+ years experience - Pharmaceutical Regulatory Submissions Experience
Looking for a full-time home-based medical writing position in the pharmaceutical/biotech industry.
Principal or Sr. Scientist in Pharmaceutical Analytical R&D, or drug development
Ideal Companies: Pharmaceutical Company or Drug development and research
Manager preclinical studies, prepare clinical regulatory documents IRB/ICB submissions IND applications
My career objectives are to focus on clinical coordinator, study manager, quality assurance, and regulatory. For the last six years I have worked in preclinical testing drugs, getting them from pre-IND to IND submission and into the clinic. The next logical career move is to work in clinical.
Ideal Companies: All companies are ideal.
Tags for this Online Resume: Clinical Coordinator, Study Manager, Regulatory, Generate Protocols, Generate Case Report Forms, Preclinical study manager, Clinical, Stereotactic Neurosurgery, Tumor Models, Subcontracts, Office Manager
Senior Director, Chicago
To obtain a leadership position for regulatory affairs expertise in the pharmaceutical/biotech industry
Tags for this Online Resume: regulatory affairs, pharmaceutical, biotechnology, clinical , manufacturing
Clinical Research Associate
SUMMARY OF QUALIFICATIONS • Foreign graduate Medical Doctor and licensed RN with more than 22 years of clinical and research experience. US citizen. Fluent in English, Russian and Romanian • Extensive training in Good Clinical Practices, ICH Guidelines, SOPs through various Sponsors • In depth therapeutic and protocol knowledge as per Sponsor’s assignment. Excellent organizational and problem-solving skills.
Ideal Companies: Biotech companies
Tags for this Online Resume: research associate, biotech, CRA, Las Vegas, pharmaceutical, health