- Legend Biotech USA, Inc. (Philadelphia, PA)
- …lead preparation of regulatory submissions (eg, pre-IND, IND, BLA).Contribute to risk assessment of new and ongoing programs, including off-target effects, ... in the treatment of multiple myeloma.Legend Biotech is seeking Sr . Director of Toxicology as part of the Clinical...Role OverviewWe are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Sr . Investigator as part of the Technical Operations team based in Raritan, NJ.Role ... OverviewThe CAR-T Sr . Investigator will be part of the Technical Operation...from end to end.Ensure thorough root cause analysis, impact assessment , and CAPA/EC determination.Work cross functionally with SME's and… more
- Merck & Co. (Rahway, NJ)
- …analytical and statistical skills with experience in data interpretation and risk assessment tools. Excellent communication, leadership, and problem-solving ... Job DescriptionThe Senior Scientist, Device Risk Management Lead,...Device Development team and with external partners.Understand and apply regulatory and compliance requirements relevant to device risk… more
- Insmed Incorporated (NJ)
- …are efficiently completed on time and in accordance with all relevant company and regulatory policies and procedures. In addition, the Senior Director will be ... and risk communication for assigned development products; perform medical assessment of individual adverse event reports generation; and review aggregate reports… more
- Formation Bio (New York, NY)
- …external partners meet GMP expectations Support preparation for and participation in regulatory inspections and due diligence audits Apply risk management ... bring new treatments to patients faster and more efficiently.About the PositionThe Sr . Manager, GMP Quality Assurance is responsible for ensuring that all… more
- Eisai, Inc (Nutley, NJ)
- …performance and reduce potential risks.Oversees vendor qualification and collaborate with Vendor Risk Assessment teams to ensure vendor strategies comply with ... that optimize cost, enhance vendor performance, and mitigate operational and regulatory risks. The Senior Director oversees vendor qualification, governance… more
- Merck & Co. (Rahway, NJ)
- …Line Engineering, Clinical Judgment, Communication, Flux Analysis, Human Health Risk Assessment , Innovative Thinking, Interpersonal Relationships, Mammalian Cell ... to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within Research Laboratories is committed to rapidly delivering… more
- Bayer (Whippany, NJ)
- …development and configuration of AI including implementation of controls. Performs a formal risk assessment based upon the intended use and configuration of AI. ... brilliant and diverse minds to make a real difference, there’s only one choice. Senior Director, Digital Governance & LMR Lead The Senior Director, Digital… more
- Insmed Incorporated (NJ)
- …compliance, and environmental protection for all Insmed locations.Key duties include risk assessment , developing safety policies, managing training programs, and ... every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive years,… more
- Formation Bio (New York, NY)
- …guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk assessment and management methodologies, with a successful track ... implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and industry best practices to support drug development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for leading company response from Deal to Contract (includes pre-deal assessment /analysis, development of business cases for Pricing Committee, offer development, ... on the Strategic Pricing and Contracting team. Works closely with senior level partners in field Account Management across channels (Institutional, Rare… more
- Amazon (Sunnyvale, CA)
- …NRTLs, and other regulatory bodies - Develop scalable mechanisms for regulatory intelligence, risk assessment , and compliance processes, planning and ... and Echo. What will you help us create? The Sr . Regulatory Compliance Engineer position requires expertise...legal team to navigate complex compliance issues - Communicate regulatory strategies and risks effectively to senior … more
- BeOne Medicines (Emeryville, CA)
- …leads and communicates CMC regulatory strategies for the assigned projects. + Lead regulatory risk assessment , identify key CMC regulatory issues and ... **_General Description:_** BeOne is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent… more
- Olympus Corporation of the Americas (Westborough, MA)
- …business objectives. + Regulatory Guidance and Compliance Execution: + Provide regulatory guidance, compliance risk assessment , and strategic input to ... This role is a digital-native leader responsible for shaping, coordinating, and managing regulatory activities across the Digital Unit (DU). The DU is a high-growth,… more
- Abbott (Pleasanton, CA)
- …articulate Regulatory plans to Senior leaders. **Cognitive Skills:** + Define regulatory strategy + Perform risk assessment or analysis. + Juggle ... mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager** to join Abbott's Heart Failure Division on-site in… more
- Citizens (Johnston, RI)
- …concern, and development/application of any potential risk mitigants. Critical Skills: + Risk Assessment + Regulatory Environment + Due Diligence + ... Perform independent commercial real estate appraisal reviews on high complexity/ risk properties. The Senior Risk ...with the applicable Citizens scope of work and federal regulatory requirements and guidance including, but not limited to:… more
- Hartford HealthCare (Hartford, CT)
- …to respond to major risk /patient safety events and provide risk and regulatory guidance * Analyze risk assessment findings and survey results to ... proactive outcomes that demonstrate commitment to high reliability safety behaviors, risk reduction, regulatory responsiveness, compliance and safe patient… more
- TD Bank (Portland, ME)
- …the US Head of Compliance Programs + Manage the Compliance Risk Assessment framework to ensure the applicable regulatory compliance risks and internal ... regulatory compliance risk management frameworks and programs, including Compliance Risk Assessment and regulatory controls management + Experience… more
- Capgemini (New York, NY)
- …+ **RAC preferred** ; advanced degree (PharmD/PhD/MS/MD). + Strong consulting toolkit: regulatory strategy, risk assessment , stakeholder management, project ... Capgemini Invent - LS Reg Affairs & Qlty - Sr Consultant At Capgemini Invent, we believe difference drives...by technology created with purpose. **Your Role** As a Senior Consultant, you'll act as a **trusted regulatory… more
- Citigroup (Tampa, FL)
- …Experience in assessing risk appetite for non-financial risks aligned with regulatory expectations. Proficient in risk assessment principles and ... activity on data risk into the Data Risk Appetite Assessment process. **Key Responsibilities:** +...the primary interface to key stakeholders such as regulators, senior management, and the Board, as it relates to… more
