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Director, Regulatory Affairs - CMC
Remote - United States, United States

Bristol Myers Squibb

NDA DMF MAA Health Authority Responses Quality Module CTA Radiopharmaceuticals IND Analytical Methods +16

Exec Senior Full Time

USD 204K+

Senior Principal Scientist, Regulatory Liaison (Sr. Director, GRL)
USA - New Jersey - Rahway

FDA Communication Global Regulatory Affairs Clinical Safety Global Regulatory Strategy IND Large Molecule Neuroscience Formulation Ophthalmology +34

Senior Full Time

USD 181K+

Associate Director, Global Regulatory Lead
Remote (US)

CTA Submission documentation Global regulatory environment Global Regulatory Requirements Marketing Approval Health Authority Interactions Drug development process Global Regulatory Strategy BLA +41

Senior Mid Full Time

USD 142K+

Senior Scientist - Biologics, Analytical Research and Development
USA - New Jersey - Rahway

DNA extraction RP Gel electrophoresis Lab Informatics IEX Separations science Antibody-drug conjugate Quality attributes Scientific publications +72

Senior Full Time

USD 111K+

Director, Quantitative Pharmacology and Pharmacometrics – Immune/Oncology - Hybrid
USA - New Jersey - Rahway

Comparator modeling Disease progression models Quantitative systems pharmacology Exposure-response models Population pharmacokinetic models Translational pk/pd Clinical trial design simulation Model-based analyses Qsp +67

Exec Senior Full Time

USD 200K+

Director, Quantitative Pharmacology and Pharmacometrics – Immune/Oncology - Remote
USA - New Jersey - Rahway

Quantitative systems pharmacology Comparator modeling Clinical trial design simulation Exposure-response models Population pharmacokinetic models Disease progression models Model-based analyses Translational pk/pd Pharmaceutical drug development +70

Exec Senior Full Time

USD 200K+

Associate Principal Scientist - Device & Combination Product Container Closure Integrity (CCI) Lead
USA - New Jersey - Rahway

Pressure decay Laser headspace analysis Vacuum decay Dye ingress Helium leak detection High voltage leak detection Method validation Container closure integrity Mass extraction +64

Senior Mid Full Time

USD 135K+

Principal Scientist / Director, GLOBAL REGULATORY CMC Biologics
USA - Pennsylvania - North Wales (Upper Gwynedd)

CMC regulatory strategies Regulatory CMC Health authorities CMC regulatory strategy BLA IND Virology Technology development Scientific Excellence +50

Senior Full Time

USD 181K+

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