Regulatory Submissions Jobs in Rahway, NJ

Job DescriptionWe are seeking an experienced and innovative Associate Principal Scientist to join the Process Analytical Technologies (PAT) team within Analytical Enabling this role you will collaborate with a cross-functional highly engaged team to advance the development pipeline and support comm...

Job DescriptionThe Pharmaceutical Analytical Sciences team has an opening for a director based in Rahway NJ. Join us and experience our culture first-hand - one of strong ethics & integrity diversified experiences exceptional science and a resounding passion for improving human health through innova...

Job DescriptionThe Mixed Modalities team within Sterile Product Development is responsible for developing parenteral dosage forms (injections implants ophthalmic and inhaled products) for small molecules intermediate modalities and biologics from preclinical development through commercialization. Ou...

Job DescriptionOur Regulatory Affairs team in General Medicine advances medical innovation to patients by establishing clear timely and robust strategies for registration enabled by engagement with global health authorities. We work across functions and geographies to advance development programs an...

Job DescriptionThis role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations our Company policies and procedures quality standards and adverse event reporting requirements internally and...

Job DescriptionWe are seeking an experienced detail-oriented Associate Director to join the Biologics Pilot Plant (BPP) Operations team within Vaccines and Advanced Biotechnologies Process Research and Development (VAXPR&D). In this role you will lead author document and drive formal investigations...

Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products in Kazakhstan while taking a step further in your professional career.Office-based in AlmatyYou will:Prepare clinical trial sub...

Job DescriptionThe Executive Director Chemistry Manufacturing Control for Biologics (Biologics-CMC) is accountable for managing a team of CMC professionals and ensuring rigor in CMC regulatory strategy as well as delivery of high quality CMC submissions for late phase new modality biologics products...

Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences) a distinguished department within our companys renowned Research and Development division quantitative scientists in partnership with other subject matter experts apply state-of-the art scientific methodologies and tools to enabl...

Job DescriptionAre you ready to make a significant impact in the world of biopharmaceuticals purification At our company we are at the forefront of innovation in the Manufacturing Division specifically within the Biologics Drug Substance Commercialization (BDSC) team. Our Downstream Purification dep...

Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences) a distinguished department within our companys renowned Research and Development division quantitative scientists in partnership with other subject matter experts apply state-of-the art scientific methodologies and tools to enabl...

Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences) a distinguished department within our companys renowned Research and Development division quantitative scientists in partnership with other subject matter experts apply state-of-the art scientific methodologies and tools to enabl...

Job DescriptionDirectors in Quantitative Pharmacology and Pharmacometrics (QP2) apply quantitative approaches to characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics inform dose selection and go/no-go decisions and shape present and defend regulatory str...

Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences) a distinguished department within our companys renowned Research and Development division quantitative scientists in partnership with other subject matter experts apply state-of-the art scientific methodologies and tools to enabl...

Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences) a distinguished department within our renowned Research and Development division quantitative scientists in partnership with other subject matter experts apply state-of-the art scientific methodologies and tools to enable the dis...