18 Drug Regulatory Affairs Jobs in Berkeley Heights, NJ
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Senior Regulatory Affairs Associate Breckenridge Pharmaceutical, Inc. - Berkeley Heights, NJ, United States regulatory affairs operations. Knowledge of eCTD publishing systems and standards, EDMS technology and related publishing tools. Working knowledge of US FDA (OGD/CDER) e-submission requirements. Strong written 7 days ago
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Senior Regulatory Affairs Associate Breckenridge Pharmaceutical, Inc. - Berkeley Heights, NJ, United States and through strategic partnerships with manufactures from around the world. JOB SUMMARY: The Senior Associate, Regulatory Affairs is responsible for supporting applications under pre and post approval 28 days ago
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Senior Director, Drug Development, Project Management - Rare Diseases (Pompe Disease) Shionogi Inc. - Florham Park, New Jersey throughout the project lifecycle. Collaborate with cross-functional teams including research, clinical development, medical and regulatory affairs, and commercial teams to drive successful drug development 2 days ago
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Associate Director, US Regulatory Affairs, Advertising & Promotion Proclinical Staffing - Morristown, NJ, United States Regulatory Affairs representative, you will work with brand on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations, company policies 8 days ago
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Associate Director-Quality Assurance (QA-CMC) Clinical Dynamix - Jersey City, NJ, United States research labs (CROs). This individual will partner with CMC, Clinical, Regulatory Affairs, and other corporate stakeholders to ensure Company’s clinical and commercial products follow cGMP framework 21 days ago
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Program Manager, Clinical Database Services Merck - Rahway, NJ 07065 Team. Strong organizational, time management, and multi-project coordination skills Broad knowledge of Clinical Development and Regulatory Affairs requirements Ability to multi-task, work independently 5 days ago
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Safety Case Management Product Specialist GForce Life Sciences - Princeton, NJ, United States preferred to be in Bachelor of Science or related healthcare degree 1-3 years of Submission Experience Demonstrated proficiency in safety database functionality *Drug Safety experience is defined as actual 23 days ago
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GPV Submission Specialist GForce Life Sciences - Princeton, NJ, United States preferred to be in Bachelor of Science or related healthcare degree 1-3 years of Submission Experience Demonstrated proficiency in safety database functionality *Drug Safety experience is defined as actual 25 days ago
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Consumer Safety Officer Food and Drug Administration - Union, Washington Services (DHHS), Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Medical Products and Tobacco Operations (OMPTO), Office of Biological Products Operations (OBPO), which 11 days ago
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Associate Director, Clinical Sciences - Ophthalmology Johnson and Johnson - Raritan, NJ for clinical data review, including medical data review, coding, in conjunction with other clinical team members. OTHER RESPONSIBILITIES / DETAILED DUTIES: * Assists Regulatory Affairs in the development of drug 8 days ago
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