- Genmab (Plainsboro, NJ)
- …organization.In this role, you will work in close collaboration with the Global Regulatory Lead (s) on a compound in late-stage development to implement the ... include, but is not limited to: Act as US regulatory lead and FDA contact person for...compliant submissions in line with the overall strategy Drive compliance with regulatory guidelines through prompt communication… more
- Genmab (Plainsboro, NJ)
- …onsite presence 60% of the time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory Affairs, the key ... passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory...working group meetings, as required for the assigned projects Lead the strategic development of briefing materials and prepare… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …marketing, market access, commercial insights and analytics, sales, medical/CMR, legal, compliance , and regulatory . Other internal relationships include Public ... contractual arrangements, SOPs, KPIs, and budget. Ensure adherence to all compliance and regulatory requirements Fiscal management: Demonstrate fiscal discipline… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …functions, and compliance across clinical development, medical, and regulatory roles/processes/SOPs Develop and implement knowledge management technology ... existing CMR employee on-boarding, cultural engagement, technical/role-specific training and GxP/ Regulatory compliance across CMR functions. Position will serve… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Programs, Patient Safety, Quality, NNI IT and Telephony, Medical Information, Compliance , Regulatory , Legal and Privacy. External relationships include Patient ... us? The Position The Associate Director will be the lead who is responsible for ensuring that all aspects...Support program vendors and professional services (including technology and platform support). Essential Functions Partners with PSS… more
- Genmab (Plainsboro, NJ)
- …technical skill development.Oversee resource allocation and ensure effective team planning. Regulatory and Audit ComplianceEnsure compliance with country-specific ... and GCP audits and inspections.Mitigate operational risks and implement regulatory changes in collaboration with stakeholders.Strategic Planning and Operational… more
- Genmab (Plainsboro, NJ)
- …architects and Genmab Security Operations TeamBusiness leaders (eg, VP Medical Affairs, VP Regulatory Affairs, GM Genmab US, IT Lead in Japan)Peers within IT&D, ... working in agile and product-oriented development teamsSolid experience with Compliance ( regulatory and industry-specific) and Security frameworksDemonstrated… more
- Genmab (Plainsboro, NJ)
- …ensure standards are met for test automation, quality, performance, security, and compliance .Stay current on leading practices and modern technology trends in ... adhering to well-architected-frameworks and delivery standards for excellence in execution. You'll lead a skilled team, with the potential to expand, focusing on… more
- Tris Pharma (Monmouth Junction, NJ)
- …materials, activities and related communications and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, ... spanning neuroscience and other therapeutic categories employing our proprietary science and technology .We truly believe that to innovate and to set us apart, we… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelinesHelp improve metrics ... PLCs, VFDs and electrical practices generally attained through hands-on experience, cGMP compliance , EHS and regulatory standards (eg EPA, OSHA and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in a fast paced and dynamic, growing environment.Strong understanding of regulatory and compliance requirementsExcellent oral and written communication skills ... we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and… more
- J&J Family of Companies (Raritan, NJ)
- …Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Lead , Technology Regulatory Compliance Business Operations to join our ... At Johnson & Johnson, we all belong. The Technology Regulatory Compliance (TRC) Business Operations Lead supports group functional operations and… more
- Integra LifeSciences (Princeton, NJ)
- …pathways to advance patient outcomes and set new standards of care. The ESG Regulatory Compliance Specialist, is responsible for the evaluation and management of ... implement, and oversee comprehensive compliance initiatives. + Strong background in regulatory compliance , particularly in ESG-related areas such as CBAM, EU… more
- dsm-firmenich (Princeton, NJ)
- …deliver exceptional customer service on projects, programs and/or processes to ensure regulatory compliance and customer satisfaction. At dsm-firmenich, being a ... ** Lead Expert Regulatory Affairs Pet Food**...authenticity is celebrated. **Your key responsibilities** + Accountable for regulatory compliance of Pet food ingredient products… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …**Job Description** **About the role:** Join Takeda as the Digital Ethics & Emerging Technology Lead in Global Research & Development (R&D) as a director, where ... of Takeda's Vision. Additionally, the Digital Ethics & Emerging Technology Lead will create procedures, communications and...digital ethics and compliance risks, and maintain compliance with privacy and emerging technology legislation.… more
- Sumitomo Pharma (Trenton, NJ)
- …junior staff + Phases I-IV Research & Development Activities + As a Regional Regulatory Lead , manage regional (United States and/or European) regulatory ... (GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory ... regulatory internal policies and processes and coordinate regulatory compliance activities at a global level… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …in global drug development regulations, regulatory submissions, lifecycle management, compliance , business systems technology and process is required. + At ... Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global … more
- Taiho Oncology (Princeton, NJ)
- …be assigned to lead /support one or two clinical development programs as Regulatory Lead (RL), responsible for regulatory strategy and execution ... or enforcements and advises the project teams on requirements to maintain compliance with regulatory activities with emphasis on research and development… more
- Merck (West Point, PA)
- …activities and all other associated Quality functions + Understands and applies regulatory / compliance requirements relative to their role. + Experience working ... Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late Development (AdVAnce)...pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be… more
- Bank of America (Pennington, NJ)
- …to area(s) of coverage **Skills:** + Advisory + Monitoring, Surveillance, and Testing + Regulatory Compliance + Reporting + Risk Management + Critical Thinking + ... and drives actions to address the root causes that lead to compliance risk issues and/or operational...metrics for risk appetite and limits, reporting violations of compliance or regulatory activities + Assists in… more
