- Axelon Services Corporation (New Brunswick, NJ)
- …the effectiveness of the Quality Systems and Training within the Global External Manufacturing (ExM) organization. Responsibilities: Process Ownership - The Quality ... Local Process Owner of one or more Quality Systems used within Global External Manufacturing - Establish and maintain relationships and communication pathways with… more
- Genmab (Blawenburg, NJ)
- …the Medical department and responsible to contribute to the implementation of the global development strategy, leading or co-leading one or more clinical trials in a ... timely deliverables. You will report to Sr Director, Clinical Research Scientist. Responsibilities Lead or co- lead one or more clinical trial(s) in a therapeutic… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- …Investments. Our global , diverse team of hundreds of forward-thinking professionals lead with agility and creativity to build solutions that bridge the gap ... includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). These investigations… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- …Investments. Our global , diverse team of hundreds of forward-thinking professionals lead with agility and creativity to build solutions that bridge the gap ... includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). These investigations… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Global Regulatory Lead ** + Location: Bridgewater, NJ or Cambridge, MA **About the job:** Our team is involved in developing regulatory ... you thought was possible. Ready to get started? **Main responsibilities:** + As Global Regulatory Affairs Lead (GRL), you will be the fully accountable… more
- Bristol Myers Squibb (Madison, NJ)
- …Develop strategic direction and provide leadership for all regulatory interactions with FDA/ global regulatory authorities + Lead regulatory dossier ... personal lives. Read more: careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products… more
- Sanofi Group (Bridgewater, NJ)
- …member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL) , the Regulatory Strategist (RS) leverages ... on the TPP, business planning, governance and committees. May be requested to lead Global Regulatory Team meetings + May represent GRT strategic position on… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** As a Global Regulatory Lead , you will be accountable for the ... (eg, Development Safety Update Reports, Investigator Brochure/ IB updates, etc.). + Lead global Regulatory Project Team (RPT) and provide oversight for… more
- Merck (Rahway, NJ)
- …Looking for someone with a growth mindset. **Position Description:** The Senior Director, Global Regulatory Lead , is responsible for development and ... final approval for all submissions and associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and regulatory … more
- Sanofi Group (Bridgewater, NJ)
- …disease. The position is within the Flu/Respiratory Syncytial Virus Franchise, reporting to the Global Regulatory Lead (GRL). We are an innovative global ... teams to ensure the delivery of business objectives. + The RS enables the Global Regulatory Lead (GRL) to provide regulatory position to support business… more
- Merck (Rahway, NJ)
- …final approval of all submissions and associated documentation. + Provides expertise as the Global Regulatory Lead to Product Development Teams and ... with worldwide regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more our company's… more
- Sanofi Group (Bridgewater, NJ)
- …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), you will leverage your regulatory expertise ... to contribute to the definition of the global regulatory strategy, to enable and drive...governance, and committees + May serve as a regional/local regulatory lead and point of contact with… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- … Regulatory Operations to ensure e-CTD compliance. + As required, serves as a global regulatory lead on a specific or assigned clinical program. ... illness. The Director, Regulatory Affairs (Early Development) provides strategic global regulatory guidance to cross-functional project teams responsible for… more
- Bausch Health (Bridgewater, NJ)
- …CAPAs. **KEY ACTIVITIES/** **RESPONSIBILITIES:** + Serve as a leadership team member for Global Regulatory Affairs + Lead and grow individuals on ... and impact. **OBJECTIVES/** **PURPOSE OF JOB:** The Senior Director of Global Regulatory Operations is responsible for directing and managing the Regulatory… more
- Bank of America (Jersey City, NJ)
- Feature Lead - (Python) Global Markets Regulatory Reporting Technology Jersey City, New Jersey **Job Description:** At Bank of America, we are guided by a ... depth and breadth in knowledge of several technical competencies. Global Markets Technology (a division of Bank of America...division of Bank of America Merrill Lynch) seeks aFeature Lead to lead and manage a team… more
- J&J Family of Companies (Raritan, NJ)
- …Johnson & Johnson Innovative Medicine is recruiting for Associate Director, North America Regulatory Lead in Global Regulatory Affairs, supporting ... of regulatory strategy through participation in product-related teams. + Provides regional regulatory input to the Global Regulatory Team (GRT) and may… more
- Bristol Myers Squibb (Madison, NJ)
- …of certain postmarketing commitments, and ensuring compliance with global regulatory requirements. **Position Summary** + Lead safety activities and ... quality, accuracy, and timeliness and in accordance with current global regulatory requirements and BMS cost effectiveness...to publications/ presentations. Clinical Development + Act as the global safety lead for assigned compounds in… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …interacts with other therapeutic area leaders and joint Alliance partners. **Responsibilities** + Lead a multidisciplinary Global Regulatory Team (GRT) to ... Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other… more
- Bristol Myers Squibb (Madison, NJ)
- …of certain postmarketing commitments, and ensuring compliance with global regulatory requirements. **Position Summary** . Lead safety activities and ... as safety sections of relevant clinical trial documents and regulatory filings. . Lead team in the...quality, accuracy, and timeliness and in accordance with current global regulatory requirements and BMS cost effectiveness… more
- J&J Family of Companies (Raritan, NJ)
- …plan, risk and opportunity playbooks, scenario evaluation and business case development). + Lead operations with Global Regulatory Team (GRT), including ... leader, driving projects forward through the translation and distillation of overall global regulatory strategy to executable plans and the coordination of… more
