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Science & Biotech Online Resumes

Regulatory Field

Regulatory Associate/ Clinical trial Associate

To be a successful and competent professional who strives to add value to the organization through a synergy of personal ambitions and organizational objectives by the effective utilization of potential and creativity.

Clinical Regulatory Affairs

Tags for this Online Resume: labeling

Associate Director, Regulatory Affairs, Philadelphia/Princeton/Horsham 15 years experience

Associate Director, Regulatory Affairs, Labeling led multiple teams to support ANDA approval and continued compliance with regulatory guidelines. Extensive negotiation with FDA reviewers to bring products to successful approval. Developed and led numerous pharma training sessions both internally and externally. Conducted company and global partner GMP and Quality Assurance audits. Successfully managed all aspects of a globa...

Tags for this Online Resume: Regulatory Affairs, Regulations, SPL, PLR, Personnel Management, Project Managemetn, Labeling, FDA Negotiation, Training, Audits, Contract Development, Pharmacovigilance

Clinical Regulatory Affairs

Regulatory Affairs/Clinical Operations Specialist

To work in a Part-Time or Consultant Clinical or Regulatory role to aid in the success of a company.

Medical Affairs, Regulatory Affairs Associate, Clinical Affairs

Doctor of Medicine recognized with clinical trial expertise in medical device, drug safety, regulatory affairs, and post-market monitoring. Strong emphasis on utilization of cross-functional skills to advance medical systems and develop process improvements. Results-driven collaborator with effective oral and written communication and presentation skills. Patient advocate and contributor to public health awareness and educa...

Tags for this Online Resume: FDA MedWatch 21 CFR 820 803, Medical Device Class III, ICD, VT / VF, Medical Affairs, Regulatory Affairs, Drug Safety, Quality Assurance and Management, Public Health, Patient Relations, Medical Communication, SAP, Excel

Clinical Trials

Clinical Trials

Clinical Regulatory Affairs - 14 Years of Experience - Near 10552

Clinical Regulatory Specialist

Looking for an opportunity that will allow me to share my skills and experience for the betterment of our global community. I have worked in this arena for quite some time and I know how to avoid the pitfalls surrounding clinical trials to ensure deliverables are met and compliance and efficacy is adhered to on every level of the study timeline.

Tags for this Online Resume: Clinical Trials , IRB Submisssion, Compliance specialist, Willing to Travel, Regulatory Document Reviewer, Essential Document reviewer, Informed Consent Reviewer, Management, Clinical Research, Ethics Committee Submission experience

Clinical Regulatory Affairs

Regulatory Affairs Specialist

Tags for this Online Resume: Regulatory Affairs, Audit, Medical Device, FDA, Project Management, Quality System