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Online Resumes with "ectd"

Clinical Regulatory Affairs - 5 Years of Experience

Science & Biotech Resumes - Clinical Regulatory Affairs Resumes - ,

Profile Regulatory Affairs Specialist with more than five years of experience in the pharmaceutical and biotechnology industries, implementing global regulatory filing strategies. Education in biotechnical engineering with deep knowledge and practical skills in managing the submission process from start to end, monitoring and tracking information, communicating with colleagues, managers and subject experts for efficiency an...

Tags for this Online Resume: Manufacturing, Packaging, Pharmaceutical, Regulatory Affairs, Biotechnical, Filing, Management, Medical, Medical Devices, Microsoft Office

Clinical Regulatory Affairs - 13 Years of Experience - Near 19711

Science & Biotech Resumes - Clinical Regulatory Affairs Resumes - Newark, DE

My background includes six years experience as a Project Manager for Regulatory Global submissions, as well as Life Cycle Management of Regulatory documents. As a Project Manager within the Submission Management Group, I provided expertise on global submission compilation and published electronic submissions compiled in RSS Application (eCTD) in accordance with Health Authority guidelines and departmental standards.

Tags for this Online Resume: Newark, DE, eCTD, RSS Application, Regulatory Publisher, Regulatory Submissions, Document Management, Legal, Management, Project Management, Publishing, Quality Assurance, Test, eCTDXpress

Biochemist - 18 Years of Experience - Near 21224

Science & Biotech Resumes - Biochemist Resumes - Baltimore, MD

QUALIFICATIONS SUMMARY * cGMP quality management experience [ QA/QC and RA]. QA experience with quality management systems (QMS) and documentation, batch record reviews, annual product reviews, SOP drafting, review and approve, investigate deviation, change and document control. Established key performance indicators (KPIs), quality by design (QbD) process analytical technology (PAT) and Quality metrics. Experienced with de...

Tags for this Online Resume: Reviews, Chemistry, CMOS, Compliance, Documentation, Drafting, Product Development, Security, Systems Development, High Performance Liquid Chromatography (HPLC), pharmaceutical

Scientist - 15 Years of Experience - Near 10954

Research Resumes - Scientist Resumes - Nanuet, NY

SUMMARY: * A pharmaceutical scientist with more than 15 years of experience supporting product development activities in an FDA regulated environment. * Seeking a position where my knowledge and skills in Pharmaceutical Product Development and CMC documentation can be applied with a potential for professional growth. * Skilled in the application of various physico-chemical analytical techniques in raw material and finished ...

Tags for this Online Resume: Enterprise Requirements Planning, Information Requests, Oracle, Oracle ERP, DSC, Product Development, Research, SAP, Filing, regulatory

Associate Director Regulatory Affairs

Science & Biotech Resumes - Agricultural Technician Resumes - North Hollywood, CA

I am seeking an opportunity to continue working in Regulatory Operations focusing primarily on eCTD submissions and document management of Regulatory, Clinical, and Quality compliance documents.

Tags for this Online Resume: Regulatory Affairs, Regulatory Operations, eCTD Submissions, Clinical Trial Master Files, Quality Assurance, Document Management