- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:We're looking for an Associate , Regulatory Operations on the Regulatory team to help us expand ... for patients with serious diseases. Reporting to the Executive Director, Regulatory Operations, you'll be responsible for the publishing, management, and submission… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director, Medical Review Committee (MRC) Operations is responsible for managing ... the operational execution of the company's Global We're looking for an Associate Director, Medical Review Committee Operations, on the Medical Review team to… more
- Insmed Incorporated (NJ)
- …expand what's possible for patients with serious diseases. Reporting to the Associate Director, Regulatory Affairs, Tactical Implementation, you'll have a ... and consistency Lead document workflows throughout document lifecycles for regulatory documents, including creation, review , approval, revision, distribution,… more
- Merck & Co. (Rahway, NJ)
- …business objectives of the brand while ensuring adherence to internal processes and regulatory guidelines.- To prepare for these launches, we are looking for an ... Associate Director (AD) to join our center of excellence.Description:-Under...point of contact on each.- Interacting with internal marketing, regulatory , and trademark legal colleagues and third- party vendors,… more
- Cipla (Fall River, MA)
- …monitoring etc. Preparation and review of the Annual Product Quality Review . Fulfil the requirement of regulatory submission while closely working with ... Job Title QA QMS Associate Organization Name InvaGen Pharmaceuticals, Inc. Location 927... regulatory teams. Prepare and review risk assessment (FMECA) for various facility, equipment, process… more
- Merck & Co. (Rahway, NJ)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... processes, including content authoring, review and finalization, and feed to the Submissions Assembly...industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems… more
- Merck & Co. (Rahway, NJ)
- …promote best practices.Prepare materials for program presentations for management review and regulatory submissions, ensuring clarity and thoroughness.Contribute ... Job DescriptionThe Associate Principal Scientist, Device Risk Management Lead, is...Device Development team and with external partners.Understand and apply regulatory and compliance requirements relevant to device risk management… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Senior Counsel, Privacy, is a strategic, business-minded, and hands-on attorney role whose ... In expanding and managing Eisai's US Privacy Program, the responsibilities of the Associate Senior Counsel, Privacy, include, but are not limited to, practical and… more
- Insmed Incorporated (NJ)
- …the future of science, we're in. Are you?About the Role:The Associate Director, Programming provides technical leadership and ensures adequate programming support ... Collaborates with cross-functional team members within Biometrics, Clinical Operations, Regulatory , and Clinical Development, as well as with external vendors.… more
- Merck & Co. (Rahway, NJ)
- …milestones, and risks within our Company and with external suppliersAuthor and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, ... DescriptionAssociate Principal Scientist - Device Technical and Engineering Lead ( Associate Director Equivalent) Our company's Device Product & Process Development… more
- Merck & Co. (Rahway, NJ)
- …DescriptionReporting into the Director, Logistics and Distribution Technology the Associate Director, Logistics and Distribution Technology will be responsible and ... to shape the technical capabilities lead a global, cross-modality technical team.The Associate Director will lead a team of technical experts responsible providing… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …profile (TPP) development, due diligence projects, and clinical- regulatory compliance. ResponsibilitiesEssential Duties and Responsibilities Clinical Development: ... execute clinical trials for respiratory products, ensuring compliance with regulatory requirements.Collaborate with cross-functional teams to develop study protocols,… more
- Aequor (West Greenwich, RI)
- …materials, processes, and products comply with cGMP standards and other applicable regulatory requirements. Review and approve work orders and job plans ... bulk drug substance operations adhere to cGMP and other regulatory requirements. Key Responsibilities: Provide quality oversight for F&E,...within Maximo. Review logbooks (paper-based and electronic), particle-generating forms, pest control… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Are you ready to realize your potential? The Position The Logistic Associate will provide multi-faceted support to materials, quality, procurement, warehouse, and ... can change quickly, while also taking into consideration the downstream effects and regulatory requirements of actions. This is an onsite role Monday-Friday based at… more
- Merck & Co. (Montgomery County, PA)
- …in the Pipeline Advertisemen We are currently recruiting for several Associate Director positions within US Marketing, covering Physician (HCP), Consumer (HCC), ... collaborating across multiple stakeholders (including sales, marketing operations, Legal, Regulatory , Medicals, etc.) to drive promotional execution. This AD will… more
- Cipla (Fall River, MA)
- Job Title : QA Document Control Associate FLSA Classification : Full-Time, Professional Work Location : Fall River, MA Work Hours: General Shift: 08:30 AM - 5:00 PM ... : $64,272 - $77,662 PURPOSE The QA Document Control Associate in a pharmaceutical environment is responsible for managing...controlled documents to ensure compliance with GMP, GDP, and regulatory standards such as FDA 21 CFR Part 11,… more
- Merck & Co. (North Wales, PA)
- …(nAMD), and retinal vein occlusion (RVO)).-We are currently recruiting for an Associate Director US Marketing, HCP Strategy - Ophthalmology. This is an exciting ... multiple stakeholders including sales, marketing operations, Learning and Development, Legal, Regulatory , Medical, etc. They will develop and track key performance… more
- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:We're looking for an Associate Director, IT Marketing Technologies, on the Information Technology team to help us ... data governance, and compliance policies (including privacy, consent, and regulatory requirements).Provide technical ownership of the Salesforce Marketing Cloud… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Ensure inspection readiness are adequately performed and may support and/or lead regulatory inspection activities at DS facilities and / or CMOs. The incumbent ... certification program to ensure adequate qualification of auditors per regulatory expectations.Risk Management and Vendor Performance: Responsible to ensure the… more
- Insmed Incorporated (NJ)
- …requires a blend of technical expertise and business acumen to ensure regulatory compliance, system integrity, and alignment with business objectives across multiple ... the application, supporting internal and external audits to ensure regulatory complianceManage technical ownership, change control, and documentation while ensuring… more
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