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Online Resumes with "global regulatory"
Scientist- 14 years-Chicago
I am a R&D Pharmaceutical Microbiology scientist, supporting new products development and marketed products, developing and validating microbiology methods, FDA and global regulatory submissions, gap assessments and remediation, VPP site R&D safety Chair, Write Lab investigation and CAPA.
Director Global Regulatory Affairs - 16 Years Experience
Quality Systems Manager/Director
Skilled leader with expertise in quality assessment, complaint management, both pre- and post-market product approval, associated regulatory reporting compliance, e.g., pharmacovigilance, field corrective action (FCA), and managing both internal and external quality assessment of operations. Designed, developed, reviewed and implemented quality, regulatory and operational systems. Developed and defined monitored account ...
Tags for this Online Resume: quality systems, regulatory reporting, quality assessment, field corrective action, complaint management, quality assurance
Energetic, results-oriented individual with established credibility and respect at FDA and EMA. An extraordinary record which includes the lead and approval on New Drug Applications (NDA) and Marketing Authorization Application (MAA)
Global Regulatory Affairs leader for a combination of RA functions. Provides clear and specific regulatory input using skills(scientist, regulator and lawyer) to provide strategic planning decisions and implementation enabling successful drug approvals. Strong leader, expertise in DD, alignment with business goals, creative, proficient with complex frameworks and integration of abstract concepts in clinical and CMC areas o...
Tags for this Online Resume: Regulatory Affairs, small molecules, CDER, CBER, FDA, EMEA, IND, NDA, CTA, IMPD, proteins, anti-infectives, cardiovascular, pain, oncology, CMC, compliance, communicator, monoclonal antibodies , Biologics, Food and Drug, Global, eCTD, health authorities, alliance management, combination products, Biologics Biosimilars , Director , pharmaceutical , Leadership, Problem solving , Innovation, experienced, IND NDA CTA MAA, business goals , biologics - pharmaceutical , biosimilars
Medical reviewer, Chicago
CAREER SUMMARY Self-motivated, detail-oriented reliable drug safety physician with 8-year-experience in pharm/biotech industry with good knowledge of global pharmacovigilance (PV) regulations, clinical medicine and bio-medical research; led and conducted single case (ICSR) medical review in therapeutic areas (TA) oncology, medical assessments, proactive signal detection and aggregate safety analysis ...
Medical & Patient Safety
A key role as an individual and/or team contributor in medical, clinical, regulatory, and preventative activities within evolving worldwide pharmaceutical and bio-technical platforms. Cultivate strong collaborative alliances; employing diplomacy in conflicting divergence, training, and influencing consensus. Resolve obstacles to positively impact both medical and business outcomes.
Tags for this Online Resume: Drug Safety, Pharmacovigilance, Medical Safety, Patient Safety, Medical Affairs
EVP Operations, Global Regulatory Affairs, Environmental Compliance
I'm a senior level professional with a broad background in manufacturing with expertise in operaions management, environmental engineering and regulatory affairs.
Compliance Manager - 4 Years of Experience - Near 08827
Qualification Summary-Operations Manager Global Regulatory Affairs and Operations: I possess a unique combination of well-developed marketing, sales, and training management skills with 4 plus years’ experience performing regulatory and operations management activities supervising all International Documentation and labeling statutory and regulatory requirements for the exportation of all Johnson & Johnson Consumer, Inc. c...
Tags for this Online Resume: FDA, Operations Manager, Regulatory Affairs, Telecommute, Export, Global, New Jersey
Worldwide Director of Regulatory Affairs
Strategic Regulatory Affairs Professional with diverse and progressive experience leading growing or established companies in the pharmaceutical, biotech and medical device industry providing global strategic regulatory direction for both new and existing products, as a primary contact facilitating preparation of international regulatory documents. Advances the development of knowledge, products, people, collaboration, c...
Tags for this Online Resume: Product Registration, CMC, International Submissions, Global regulatory, BLA, INDs, Orphan Drugs, Project Management, Bilingual, International regulations
Research
To obtain a challenging position within the Pharmaceutical industry or medical devices industry that will allow me to use my experience to play a key role in Clinical Research studies and projects, and/or product development with medical devices.
Tags for this Online Resume: Clinical Pathology, laboratory method development, IQ, OQ, PQ, instrumentation, validation of medical devices, Regulatory, GLP, GCP, IRB, TMF, Project Manager, Documentation Specialist, Scientist, Archives
Global Regulatory and Scientific Documentations Intern
Highly motivated and committed individual looking for a career in Regulatory Affairs as well as Research and Development in the pharmaceutical industry. Currently I am working at Bristol-Myers Squibb in the Global Regulatory Department. Works well under pressure in a sustained energetic manner. Comfortable multi tasking in a rapidly changing environment. Given my science education as well as my previous work experience with...
Tags for this Online Resume: Lab Technician , Research , Regulatory , Clinical , Healthcare, Hospital , Pharmaceutical
Clinical Regulatory Affairs - 13 Years of Experience - Near 19711
My background includes 13 years’ experience in the Pharmaceutical Industry at AstraZeneca Pharmaceuticals in Global Regulatory Submissions and Life Cycle Management of Regulatory documents. This includes 6 years’ experience as a Project Manager for Regulatory Global submissions. As a Project manager within the Submission Management Group, I provided expertise on global submission compilation and published electronic submiss...
Tags for this Online Resume: Newark, DE, Life Cycle Management, Regulatory Global Submissions, Pharmaceutical Industry, RSS Application, eCTD Publisher, electronic submissions, Regulatory Publisher, Management, Cardiovascular, Document Management, Legal, Pharmaceutical, Project Management, Publishing, Quality Assurance
