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Online Resumes with "Regulatory submissions"

Featured Profile

Toxicologist/Preclinical Safety/Regulatory Affairs

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.

Director Regulatory Operations, Princeton, NJ

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.

Tags for this Online Resume: ectd, regulatory, submissions, publishing, electronic applications, validation

Clinical Research Associate

To obtain a Clinical Research Position in the Minnesota Area.

Tags for this Online Resume: Knowledge of 21 CFR, Quality System Regulation (QSR), Medical Device Reporting, Regulatory Compliance , Regulatory Submissions , ICH GCP Guidelines

Regulatory Affairs/Quality Assurance Specialist -- 5 years experience -- New Jersey

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.

Lead Regulatory

Tags for this Online Resume: Regulatory Submissions, IRB 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.

Ideal Companies: Johnson and Johnson, Celgene, Sanofi, Novo Nordisk, Bristol-myers Squibb,

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

Medical or Health Services Manager - 20 Years of Experience - Near 32765

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...

Tags for this Online Resume: Orlando, FL, VP Business Development, VP Sales, Executive, Medical Device, Medical Laser, Regulatory

Featured Profile

Quality Coordinator - 14 Years of Experience - Near 10603

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.

Ideal Companies: Pharmaceutical, medical device, Biotech, healthcare

Tags for this Online Resume: Regulatory Affairs, Quality Assurance, Drug Safety, Medical Documentation specialist, Submisisons operations, FDA compliance, Annual Reports, project leader

Chemical Engineer/Biomedical Engineer - 8 Years of Experience - Near 60629

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...

Tags for this Online Resume: Innovative, new product development, technical leader, feasibility, root cause analysis, verification, design, method development

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

Medical Scientist - 20 Years of Experience - Near 86314

Obtain permanent senior medical writer position in CRO or pharmaceutical or medical device company (regulatory or publications).

Tags for this Online Resume: Medical Writing, Regulatory Submissions, Publications, CTD, NDA, PMA, Clinical Scientist, CSR, Protocols


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