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Online Resumes with "Clinical CMC"
Senior Director, Chicago
To obtain a leadership position for regulatory affairs expertise in the pharmaceutical/biotech industry
Tags for this Online Resume: regulatory affairs, pharmaceutical, biotechnology, clinical , manufacturing
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
Biochemist
Tags for this Online Resume: Regulatory Affairs , FDA EMA, NDA MAA, Compliance , Clinical - CMC, Leadership, Experienced IND CTA, Proficient- Pragmatic , Innovation
Case Management Manager - 2 Years of Experience - Near 28105
Established in Family Practice health care, transitioning to social work to develop/strengthen case management, counseling with children, adults, older adults, and families. I am skilled in providing psychosocial assessments and interventions to improve and maintain social, emotional, and physical well-being of patients/clients. I have 5 years of experience in working with geriatrics in a Geriatric Clinics with CMC. I am tr...
Tags for this Online Resume: Charlotte, NC, Rock Hill, SC, Lancaster, SC, Columbia, SC, Social Worker, counselor, discharge plan
Life Scientist - 20 Years of Experience - Near 19335
Summary An experienced toxicologist with a successful track record supporting drug discovery research and development to progress biologic-based and/or small molecule drug candidate (s) through all phases of nonclinical development (Phase 1-4). Multiple successful NDA approvals, along with BLA approval for a respiratory biologic and successful IND submissions. Extensive and broad based expertise in conceptualizing and desig...
Tags for this Online Resume: Audit, Research, Test, Toxicology, Protocol, Compliance, Training, Evaluate, Medical, Medical Devices, oncology, protocol, pharmaceutical, ich, nonclinical, Regulatory Affairs, Quality Assurance, GXP
Life Scientist - 20 Years of Experience - Near 19335
Summary An experienced toxicologist with a successful track record supporting drug discovery research and development to progress biologic-based and/or small molecule drug candidate (s) through all phases of nonclinical development (Phase 1-4). Multiple successful NDA approvals, along with BLA approval and successful IND submissions. Extensive and broad based expertise in conceptualizing and designing nonclinical developmen...
Tags for this Online Resume: Audit, Research, Test, Toxicology, Protocol, Compliance, Training, Evaluate, Medical, Medical Devices
