- Catalent (Manassas, VA)
- … regulatory submissions, reviewing new and revised SOPs and guidance pertaining to Regulatory Affairs and regulatory compliance . Will prepare for and lead ... Associate Director , Regulatory Affairs Position Summary: Catalent... regulatory meetings, designing regulatory compliance strategy to ensure … more
- George Washington University (Washington, DC)
- …and resolve compliance , service and operational issues. The Director , Regulatory Oversight position responsibilities include overseeing the activities ... I. JOB OVERVIEW Job Description Summary: The Director , Regulatory Oversight position reports to...the Executive Director for Research Integrity and Compliance , oversees quality assurance and quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to… more
- Fidelity TalentSource LLC (Boston, MA)
- Job Description:The RoleThe Director of Product Disclosure Policy and Regulatory Strategy is responsible for establishing and administering guidelines for the ... Fund Investment Operations (FFIO) regulatory readiness focused on emerging regulatory matters impacting our business. The Director will:Be the primary… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …risk assessments to prioritize investigations based on potential impact on product quality , patient safety, and regulatory compliance . Address recurring ... in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the… more
- Insmed Incorporated (Bridgewater, NJ)
- … Director of Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance , the Director , ... of compliance requirements, work with critical suppliers to ensure quality , consistent supply.Review and monitor all lab processes to ensure they follow… more
- Catalent (Philadelphia, PA)
- …guidance to the Quality Disposition, Materials Sampling Quality Assurance, Regulatory and Compliance Quality Assurance, and Validation Quality ... Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality...and effective quality system that delivers reliable, high- quality products that meet all customer and regulatory… more
- Option Care Health (Bannockburn, IL)
- …hiring, developing, and retaining a diverse workforce. Job Description Summary:The Director , Compliance Investigations is responsible for developing and ... investigations. * Defining, developing, and implementing strategies to identify and address regulatory and compliance risks and trends. * Ensuring that Option… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Director of Quality Operations provides direct support for all Manufacturing and Quality activities. This position supports the ... to oversee all quality aspects within the Quality Assurance Unit ensuring compliance with federal...Quality Systems to ensure no critical complaints or regulatory actionsProvide support for the Internal Audit ProgramPerforms other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in-built controls in relevant process steps to ensure adherence to regulatory compliance .Monitor effectiveness of implementation of applicable clinical ... Reviews of respective product profile to ensure appropriate management review of all quality and compliance related topics including the review of Key … more
- Merck & Co. (Rahway, NJ)
- …communication, and serves as Quality spokesperson, on a variety of Quality or compliance -related issues.Interprets complex regulatory requirements for ... in a matrix/management environment.Lead the resolution of business practice, Quality and/ or compliance issues of broad scope and highest level of complexity.… more
- Merck & Co. (Millsboro, DE)
- …DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/ ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...species including chickens, turkeys, dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory … 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...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Manage and oversee all assigned projects/products/processes. Assist the Director /Associate Director in assuring Novo Nordisk compliance with internal SOPs ... regulatory agencies. Supervise designated personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager … more
- Tris Pharma (Monmouth Junction, NJ)
- …The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs, Manufacturing, Quality , etc. to identify, evaluate ... opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety...potential risks mitigation, etc. Collaborates with appropriate clinical, medical, quality and regulatory counterparts and others across… more
- Novo Nordisk Inc. (Chicago, IL)
- …hires during on-boarding and provide on-going support, as determined by Field Director Ensure personal compliance with all internal/external SOPs/rules and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Catalent (Harman, WV)
- …stakeholder satisfaction.Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, ... to ensure a process of business recovery of cost changes as appropriate.Maintain compliance with all regulatory requirements and ethical standards related to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the CMR training strategy Ensuring CMR employees receive training on regulatory compliance , quality standards, GxP requirements and industry-specific ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one...representative; Liaise with global and HQ counterparts to promote quality and consistency across regions. Ensure compliance … more
- Option Care Health (Bannockburn, IL)
- …to hiring, developing, and retaining a diverse workforce. Job Description Summary:The Director , Quality and Risk Management shall have oversight responsibility ... emphasis on integrating Quality Improvement and safety processes as appropriate. The Director , Quality and Risk Management reports to the VP, Quality … more
