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Online Resumes with "Regulatory submissions"
I am a Board-Certified toxicologist with extensive regulatory affairs experience. I have been in the field 20+ years. I have authored regulatory submissions, designed toxicology programs, and conducted due diligences across therapeutic areas.
I am a regulatory affairs operations and publishing professional who has over 16 years experience in the publishing and management of Regulatory submissions. Expertise in the eCTD submission format for IND,NDA and MAA.
To obtain a Clinical Research Position in the Minnesota Area.
I am a Regulatory Analyst with 5 years of professional experience in developing and implementing Quality System documentation and regulatory submissions for medical devices, pharmaceuticals and biotech products. Thorough understanding of business processes such as R&D, nonclinical, clinical, pre-approval and post-approval submissions.
Director- Global Operations- 20+ years of experience- Manufacturing of Biologicals-Technical Transfer-develop people-GMP compliance-Regulatory submissions-
Expertise in managing Supply chain for a 1.5 Billion dollar Medical Device Reagents business. Technical, Quality and Regulatory background to manage the business under FDA compliance.
Tags for this Online Resume: Manufacturing Biologics, Protein Purification, Microbial Fermentation, CGMP, FDA Compliance, Protein Characterization, Quality Control, Regulatory Submissions, Quality Audits, Six Sigma Black belt
My vast experience in the medical device industry has afforded me the opportunity to become proficient in many functional areas of business throughout virtually all medical (hospital, surgical, outpatient and in office) specialties and procedures. These encompass operations, sales, marketing, building sales forces in the US and throughout the world, design and development, regulatory submissions/compliance, clinical resear...
I am looking for something new and challenging where a company is willing to train someone in a new field to grow and contribute to the company's goals.
Objective: To serve the medical device community as a technical leader in new product development and continuous product improvement. Innovative Research & Development Engineer with experience designing, implementing, and testing medical devices for fluid management and processing. Technical leader and contributor on cross-functional teams in new product development, risk management, product testing, and DHF remediation/Reg...
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...
Obtain permanent senior medical writer position in CRO or pharmaceutical or medical device company (regulatory or publications).
To work learn and grow with an organization to reach a high level in Regulatory Submission Management hierarchy and be instrumental in driving it beyond its mission by adhering to its values and cultures and utilizing my potential and talent to its fullest.
Tags for this Online Resume: Regualatory Publishing, Regulatory Affairs, Submission Manager, Health Authority , ISI Tool Box, eCTDXpress, ISI Publisher, Liquent, Insight Publisher, CMC Documentation, USFDA, EMEA, MHRA