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We’re immediately hiring a US Regulatory Affairs Lead for Personal Care and Sleep who is proficient in cosmetics, dietary supplements, and OTC products. US Regulatory Affairs Lead, Personal Care Brands page is loaded.
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This position reports to VP, CDMA with a dotted line reporting relationship to the CSO. The Senior Director CDMA will interact with internal colleagues in Research and Development (Clinical Development & Medical Affairs, Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs, Pharmacovigilance) Strategy/Portfolio Management,Commercial and Operations functions.
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This means that, in addition to our blockchain expertise, part of our operational needs are very similar to that of a traditional investment manager: trade management, service provider relations, book reconciliation, audit, tax, and regulatory compliance, and the like.
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Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine the impact of proposed labeling changes on product promotion. he Associate Director, Advertising and Promotion, Prescription Drug Products, reviews, approves and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements.
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Minimum of 10 years of experience as a regulatory toxicologist (study director/monitor and/or project lead) in the pharmaceutical or biotechnology industry or within a regulatory authority.
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He/she manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. He/she defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global locations or contract manufacturing organizations (CMOs), or alliance partners.
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Partner with Manufacturing, Product Support, Microbiology, Regulatory Affairs, Quality Control Labs, Engineering and Compliance. Support/participate in external regulatory audits (FDA, TUV, Health Canada, Customers, etc.
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Is accountable for inspection readiness of external data documentation filed/archived in Trial Master File (TMF) according to applicable Daiichi Sankyo and regulatory requirements. This position also ensures quality delivery of all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions.
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Client Innovative Medicines is seeking an experienced IT Solution Architect to support systems product development in Global Regulatory Affairs. Partner with Product teams, Client Technology Services and other architects to design scalable, flexible and supportable technical systems that drive business value for client Global Regulatory Affairs.
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Provide hands-on statistical programming support to regulatory submission and help submission team in quick turnaround in response to regulatory agencies. datasets as well as TLFs generated by statistical vendor, ensure correct and effective vendor programming implementation, and expedite the preparation of regulatory submissions.
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At least 5 years of experience in a Solution Architect role serving the Regulatory Information Management domain. 7+ years of experience supporting pharmaceutical content management solutions and integration (Authoring, Submissions, Archival, TMF, Quality, DAM, PLM.
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Partners with internal stakeholders including CSPV, Regulatory, Clinical, Medical Affairs, HEOR and other stakeholders to ensure expectations are clearly defined and met across participating teams.
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Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies. Develop and validate programs (SAS or R) to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies.
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Influence and collaborate with cross-functional teams including Marketing, Brand Activation, Commercial, Medical, Regulatory, IT and Business Insights. Compliance: Ensure systems are in place to ensure compliance with Regulatory Authority and corporate requirements and HCC requirements.
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Ensure close collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs, etc. Develops the process for ensuring that analysis data sets and outputs are compliant with regulatory requirements, including CDISC ADaM data set specifications, reviewer’s guides, etc.
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regulatory job Title: sr regulatory affairs associate in Bridgewater, NJ
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