- Parexel (Trenton, NJ)
- …motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior /Consultant. This role is critical to ensure ... contingency plans for CMC -related scenarios - Represent CMC Regulatory Affairs in cross-functional...for a Consultant level role, 7+ years for a Senior Consultant - Proven success in preparing regulatory… more
- Organon & Co. (Jersey City, NJ)
- …**The Position** The Senior Scientist is responsible for implementing Regulatory Chemistry, Manufacturing & Controls ( CMC ) strategies for assigned small ... for the preparation and review of information required for development of regulatory CMC dossiers for commercial products. Primary responsibilities include, but… more
- Parexel (Trenton, NJ)
- …strategic thinker with a passion for navigating the complex world of global regulatory affairs ? Do you thrive in cross-functional environments and love ... a dynamic and experienced Post-Approval Regulatory Strategy Lead to join our Regulatory Affairs team. In this pivotal role, you will be responsible for… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional interactions with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, ... Lead will be responsible for ensuring the fulfillment of regulatory requirements and commitments as well as execution of...Manufacturing and Controls ( CMC ), medical affairs and business development are critical to the success… more
- Parexel (Trenton, NJ)
- …motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior /Consultant. This role is critical to ensure ... contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional...for a Consultant level role, 7+ years for a Senior Consultant * Proven success in preparing regulatory… more
- Bausch + Lomb (Trenton, NJ)
- …in assigned due diligence activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA submissions. + ... preferred + Minimum of 8 years in recent experience in strategic pharmacuetical Regulatory Affairs . This position does not work with medical device, cosmetics… more
- Sumitomo Pharma (Trenton, NJ)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the ... Global Regulatory Affairs (GRA) team based in the US....the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of … more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… more
- Bristol Myers Squibb (Princeton, NJ)
- …projects. + Identifies issues or is assigned projects that will impact BMS, regulatory affairs or projects and provides strategies for dealing with them. ... preferred. + 8-12 years pharmaceutical industry experience, including 6-8 years in regulatory affairs . Global experience strongly preferred with command of US… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
- Sanofi Group (Morristown, NJ)
- …toward all GPT members, including eg project management, clinical operations, regulatory , safety, translational medicine, statistics, CMC , IA **Basic ... Global Project Head (GPH) is delegated various responsibilities by the Senior GPH and/orTherapeutic Area Head to provide leadership, supervision, and coordination… more
- Bristol Myers Squibb (Princeton, NJ)
- …late-stage challenges (eg, trends in disease area therapeutic advances, and evolving regulatory , patient advocacy and market access environments) to create a vision ... development and enable continuous improvements without compromising quality. + Engages senior leaders and functional area stakeholders to ensure alignment of program… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …by closely working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs , Marketing, Market Access, Medical Affairs , Drug ... effectively with colleagues in Supply Chain, Accounting, Market Access, Quality Assurance, Regulatory Affairs , Finance, etc. of Mitsubishi Tanabe Pharma Group,… more
