Latest Drug Regulatory Affairs jobs in Union, NJ

20 Drug Regulatory Affairs Jobs in Union, NJ

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 3 days ago
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 17 days ago
Vice President, Oncology Breast Therapeutic Area Medical Head, MD at Pfizer Pfizer - New York City, New York potential of our existing and future commercially available medicines. + The role will partner closely with Pfizer Oncology stakeholder groups (including Research, Early and Late Development, Regulatory 11 days ago
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 24 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 29 days ago
Senior Clinical Director Merck - Rahway, NJ 07065 with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects. Assist the Executive Director in ensuring 14 days ago
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 19 days ago
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 21 days ago
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 4 days ago
Senior Scientific Integrator, Regulatory CMC Dossier Johnson and Johnson - Raritan, NJ authorities * Perform reviews of dossier documents prepared by other team members for completeness, accuracy, and structure * Work closely with Regulatory Affairs, Analytical Development, API Process 6 days ago

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