Manage applications to the FDA for Certificates to Foreign Government (CFG), and Export Certificates. Review, approve and submit FDA invoices, FDA submission check requests and FDA forms. Manage requests for regulatory document apostilles and legalization services. Manage Regulatory calendar for the RA team and leadership. Provide awareness of team meetings, holidays, lea

Reviews and interprets regulations/guidance documents to develop regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, IND & CMC strategies, submission requirements, timing and risks. Interact with US FDA and acts as a liason with Corporate International RA and/or country RA to define submission content, expedite pend

The Director of Privacy, International will interface with Quest Diagnostics colleagues internationally and domestically on in country and cross border privacy and data protection issues. Working with the Privacy Office, Compliance and Legal, provide advice, guidance and support to a broad range of corporate functions related to the application of privacy laws, regulation

OF POSITION Independently authors, compiles, reviews, and schedules high quality regulatory submissions in adherence with standards that are fully compliant with FDA and ICH requirements within company timelines. Plans, coordinates and writes, clear, concise and accurate, responses to inquiries from FDA resulting from their review of the submissions. Submissions will inclu

The role is a technical lead that requires deep knowledge, skills, and experience in designing and carrying out clinical analytics. The position is a key team member collaborating in a multi disciplinary business environment with colleagues across the enterprise to lead clinical performance analytics, development, and reporting that deliver actionable clinical insights to

The role is a technical lead that requires deep knowledge, skills, and experience in designing and carrying out clinical analytics. The position is a key team member collaborating in a multi disciplinary business environment with colleagues across the enterprise to lead clinical performance analytics, development, and reporting that deliver actionable clinical insights to

The role is a technical lead that requires deep knowledge, skills, and experience in designing and carrying out clinical analytics. The position is a key team member collaborating in a multi disciplinary business environment with colleagues across the enterprise to lead clinical performance analytics, development, and reporting that deliver actionable clinical insights to

The role is a technical lead that requires deep knowledge, skills, and experience in designing and carrying out clinical analytics. The position is a key team member collaborating in a multi disciplinary business environment with colleagues across the enterprise to lead clinical performance analytics, development, and reporting that deliver actionable clinical insights to

Continuously monitor updates to online gaming and sports wagering regulations Work cross functionally across departments within the Company, often switching between competing priorities on a daily and weekly basis Assists with periodic reviews of products and services, ensuring compliance with regulations or detecting potential areas of non compliance Provide all departme

Contribute to the strategic vision and integrates a broad range of ideas regarding setting the strategy around gathering, organizing, and extracting qualitative and quantitative relationships and trends from large amounts of data Recognize across the organization for organizing and developing data warehouses for optimal decision support Lead the design, development and im

QC Lab Operations Specialists for Tris Pharma, Inc. to work at our Monmouth Junction, NJ loc. Perform duties to accord w/ company policies + procedures, SOPs, + state, federal + local laws. Test raw materials, In process, extended release Intermediates, Finished Product + Stability samples, incl dissolution, assay, preservatives, Related Compounds analysis, content/blend

The IT Business Partner will work closely with Human Resource leaders to maximize the impact of IT capabilities on business performance and ensure IT services meet business needs and objectives.Reporting to the Head of Enabling Functions Business Partner lead, this person will play a critical role to ensure the Human Resource function leverages technology solutions to ach

One of the top strategic priorities of Zoetis is to power our business through digital solutions and data insights. Strong data governance is imperative in order to optimize the value created from our digital and data assets. As such, Zoetis is establishing a Data Governance program to improve the quality and consistency of our data, increase efficiency and productivity o

Compliance Analyst Remote Job Locations US NJ EATONTOWN | US NJ Remote Job ID 2024 3667 Category Compliance & Audit Type Regular Division A&H Crum & Forster Company Overview Crum & Forster (C&F) with a proud history dating to 1822, provides specialty and standard commercial lines insurance products through our admitted and surplus lines insurance companies. C&F enjoys a f

The Interoperability Regulations and Standards, Director will work with key external stakeholders to summarize lab related industry standards and regulations and translate any business impact to internal stakeholders. When impactful, this role will be responsible to coordinate internal stakeholders to further assess any impact and help establish solutions. The role will c