- Haleon (Warren, NJ)
- …that's uniquely ours. Care to join us. It isn't a question. The **Sr Manager, US Regulatory Operations & Compliance ** , is responsible for regulatory ... application within the organization. Specifically, the position is accountable for compliance with evolving regulatory frameworks and relationships with the… more
- RELX INC (Horsham, PA)
- …regulations; host external audits and demonstrate QMS compliance to clients and regulatory bodies. + Regulatory Compliance : Stay abreast of current ... regulations, ISO and industry standards. + Audit Management : Lead internal audits to assess compliance with...staff and other departments on quality system processes and regulatory requirements. + Training Curriculum and Compliance … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …The RA Quality & Compliance Excellence function, part of RA Business Operations , collaborates across Global Regulatory Affairs (GRA) to ensure that ... the creation, curation, and delivery of high-quality training materials covering regulatory compliance , product knowledge, leadership development, and soft… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …alignment with the global regulatory strategies in collaboration with Franchise Lead and cross functional stakeholders in compliance with the appropriate ... regulations. You will act as the Global or Regional Regulatory Lead on complex or multiple products,...+ BA/BS with 12+ years' relevant experience. + Extensive regulatory , quality, compliance or related experience in… more
- Merck (Upper Gwynedd, PA)
- …have excellent communication and collaboration skills and will work closely with a global regulatory lead (s) to help develop and implement a global strategy for ... attending Agency meetings as needed to assist the global regulatory lead . + Participating as an active... regulatory strategy as needed to colleagues in Regulatory Operations , Clinical Safety, Labeling, Regulatory… more
- Novo Nordisk (Plainsboro, NJ)
- …Designers, Marketing and Supply Chain. Relationships Reports to labeling management in Regulatory Operations (RO), engaging with key company personnel within ... and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks related to final printed pharmaceutical labeling for launch and… more
- Bausch Health (Bridgewater, NJ)
- …progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and post-approval/ regulatory compliance for assigned ... and registrations + Manage interactions with other BHC functions (eg, Quality, Compliance ) during Regulatory Authority inspections + Provide regulatory … more
- Novo Nordisk (Plainsboro, NJ)
- …existing CMR employee on-boarding, cultural engagement, technical/role-specific training and GxP/ Regulatory compliance across CMR functions. Position will serve ... serve to act as an advisor to North America Operations (NAO) CMR organization on all aspects of new...maintenance of technical training across all CMR functions, and compliance across clinical development, medical, and regulatory … more
- AbbVie (Branchburg, NJ)
- …chain and supporting functions & areas of the site + Ensure cyber resiliency, compliance and data integrity regulatory standards are maintained and adhered to ... and fulfilled. We are now recruiting for Site BTS Lead to join our Branchburg site. The Site BTS...demand: IME, Quality, Supply Chain, BTS in alignment with Operations ' strategic priorities. + Liaise with Global BTS, OES,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …record keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Meta (Trenton, NJ)
- …execution across various workstreams and business areas. **Required Skills:** Global Sales Operations - Rx Operations Lead Responsibilities: 1. Develop ... execution of complex operational initiatives, leveraging expertise in optical operations and program management. The Prescription (Rx) Product Operations… more
- J&J Family of Companies (Raritan, NJ)
- … functions, including J&J Business Unit Quality organizations, and J&J Enterprise Regulatory Compliance + Creating an environment which encourages the company's ... with the Global Audit & Assurance and the J&J Regulatory Compliance functions to help inform their...& Control Capabilities in service of JJT-TS and Quality Operations **People Leadership** + Lead a globally… more
- Colgate-Palmolive (Piscataway, NJ)
- … Compliance :** + **Ensure high standards of quality and regulatory compliance are maintained across all operations ** + **Uphold and drive compliance ... for all manufacturing and technology facilities globally** + **Ensure the enforcement of regulatory compliance , maintaining the integrity of our brands** + **Act… more
- Sanofi Group (Morristown, NJ)
- …Ready to get started? **Main Responsibilities:** + Ensures the Quality and Regulatory Compliance of products sub-contracted to external entities on behalf ... This role reports to the Senior Director, Quality and Regulatory , EM-NA and is part of team that has...providing Quality oversight for 3rd Party Manufacturing (Contract Manufacturing Operations ) to oversee activities of QA/QC and compliance… more
- Actalent (Sellersville, PA)
- …all changes are evaluated, documented, and implemented in compliance with regulatory requirements and company standards. Responsibilities + Lead and manage ... Job Title: Deviation/Change Control/CAPA Lead Job Description The High-Level Quality Compliance...and change controls are documented, analyzed, and resolved in compliance with regulatory requirements and company standards.… more
- Cardinal Health (Trenton, NJ)
- …continuity, significant incidents, etc.). + Hazard Recognition, Evaluation and Control / Regulatory Compliance (35%): Leads in the management of operation ... the development of risk mitigation plans. Partners with operation leaders to ensure compliance with Company and regulatory requirements. Analyzes key EHS metrics… more
- Ascendis Pharma (Princeton, NJ)
- …lifecycle, from negotiation and execution to renewal and termination. Ensure compliance with company policies, regulatory requirements, and contractual ... accurate calculation, timely payment, and reconciliation of rebate liabilities in compliance with regulatory requirements and contractual obligations. Involves… more
- Bank of America (Pennington, NJ)
- …needs and to gain competitive advantage **Skills:** + Subject Matter Expertise + Regulatory Compliance + Interpret Relevant Laws, Rules, and Regulations + ... 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 + Manages the… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** The Global Clinical Lead , Digital and AI reports directly to the Global VP, Clinical ... across the Digital and AI business unit portfolios. This individual will lead the development, execution, and closeout of evidence generation activities to support… more
- Merck (West Point, PA)
- …with the overall business objectives for launch preparedness and enhanced robustness, regulatory , and compliance requirements of the company. + Provide executive ... their commitment to the technical transfer vision. Risk Management, Compliance Oversight & Decision Making: + Lead ...to ensure patient safety and product quality. + Ensure compliance with all regulatory requirements and quality… more