- Aequor (Newbury Park, CA)
- …archival systems/electronic document repositories also useful. Coordination and execution of regulatory submissions in compliance with corporate standards and ... zone based on business needs in the evenings. Ideal Candidate: Previous Regulatory Experience professionally is highly preferred. Knowledge of FDA. Degree in life… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and ensures that material is fully released prior to shipment to siteEnsures compliance with all domestic and foreign regulatory requirements but may seek ... oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence...and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …based on potential impact on product quality, patient safety, and regulatory compliance . Address recurring deviations and health authorities' observations ... in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Senior Director, Head Global PV Quality (DSI/DSE) reports to the Global Head ... RDPVQA, and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global PV Quality teams… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Technician, MaintenanceThe Senior Maintenance Technician is responsible for providing equipment troubleshooting and ... Quality, Automation, Technology, and other groups as required.The Lab Senior Maintenance Technician will provide maintenance supporting vaccine process equipment… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Fermentation Operations Technician (Days) This position is in direct support of our Upstream Fermentation manufacturing ... Tangential Flow Filtration, Process Monitoring, Sampling, and area cleaning. As a Senior Technician you will be an energetic leader with strong interpersonal,… more
- Merck & Co. (Rahway, NJ)
- …and proactively and result in outcomes that demonstrate the Company's commitment to regulatory compliance . Ensures that a cross-functional team (eg Quality & ... real-time, proactive advice and guidance. Escalate potentially significant inspection findings/ compliance risks/impact to our Company Senior Management. Develops… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Millsboro, DE)
- …and unregulated species including chickens, turkeys, dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory requirements for ... Delaware seeks to add an Attending Veterinarian in the role of Associate Director.This position will have overall responsibility for oversight and administration of… more
- Eisai, Inc (Nutley, NJ)
- …to the Senior Director, Omnichannel Marketing (HCP and Patient). The associate director will also partner closely with key internal partners to deliver ... customer journeys and strategies across target audiences as well as ensure regulatory /legal and compliance requirements are met.This role requires strong… more
- Merck & Co. (North Wales, PA)
- …Responsibility Essential function(s) includes, but is not limited to: Reporting to Senior Management of the Medical Device and Combination Product (MDCP) Quality ... Assurance Operations team, the Associate Director Quality Engineering & Quality Assurance is responsible for independent compliance support of Medical Devices… more
- Merck & Co. (Rahway, NJ)
- …to ensure GRACS contractual obligations and commitments are met while maintaining regulatory compliance .Work closely with the Corporate Business Development, our ... Job DescriptionUnder minimal guidance of the Senior Director or Director, Business Development Execution, the primary function includes coordinating various GRACS… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ROI, KPI, financial milestones and related payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research, ICH GCP ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Clinical Trial sites. Accountable for overall performance management of Senior Supply team, who contribute to the planning, execution… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …assets are easily accessible and properly utilized. Relationships Reports to the Associate Director of Content Management; Provides direct support to the Digital ... multiple NNI internal functions such as Brand Managers, Omnichannel teams, IT, Regulatory and Commercial Insights & Analytic, as well as external operational vendors… more
- Eisai, Inc (NJ)
- …this is your profile, we want to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related to the ... and functional service providers for Eisai's R&D functions. This role will ensure compliance with key processes and manage the outsourcing team. The ideal individual… more
- Insmed Incorporated (Bridgewater, NJ)
- …of Record and media agencyWork closely with cross-functional partners including Legal, Regulatory , Compliance , and Medical Affairs, to align and compliantly ... in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director, HCP Marketing will be a key member...of our culture. This position will report to the Senior Director, HCP and Payer Lead. This position does… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration… more
- ADM (Kennesaw, GA)
- **83651BR** **Job Title:** Regulatory Senior Associate **Department/Function:** Legal, Compliance , Regulatory Affairs, Corporate Security **Job ... Description:** ** Senior Regulatory Affairs** **Manager - Kennesaw, GA** This is a...the global RSA community and cross-functional teams to ensure regulatory compliance of the products in the… more
- Hawaiian Electric (Honolulu, HI)
- Senior Associate General Counsel ( Regulatory & Litigation) Date:May 21, 2024 Location: Honolulu, Hawaii (HI), US, 96840 Company: hawaiianel We recognize our ... related issues affecting the Companies, including: assessment of legal, regulatory compliance and business risk; representation of...Kahului - Maui Hiring Range:The hiring range for the Senior Associate General Counsel ( Regulatory … more
- Robert Half Legal (Des Moines, IA)
- Description We are seeking a Senior Regulatory Affairs Associate based in Des Moines, Iowa. This role will involve overseeing regulatory support and ... compliance within the parameters set by various regulatory agencies such as USDA and FDA. The successful...* Engage with government agencies and business partners on regulatory issues * Provide required documentation to partners and… more
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