- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing ... global regulatory strategies and plans to enable efficient, competitive product development for assigned programs. This role will provide regulatory input to … more
- Ralliant (Raleigh, NC)
- …a key legal advisor and strategic partner to the **_Assistant General Counsel, Global Regulatory and Government Affairs_** providing expert legal counsel and ... leadership across Ralliant's global regulatory and government affairs portfolio. The ideal candidate is a licensed attorney with deep experience in international… more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs ... VP of Regulatory Affairs, lead the development and implementation of global regulatory strategy plans to facilitate efficient and driven product… more
- Insmed Incorporated (NJ)
- …understanding of US, EU, and Japanese regulations for human drugs/biologics.Knowledge of global regulatory guidance documents and regulations with emphasis on ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...science, we're in. Are you?About the Role:The Associate Director, Regulatory Affairs, CMC will be responsible for reviewing the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on regulatory guidelines including FDA, EMA, ICH-GCP, and other global regulatory requirements Coordinate mandatory compliance training for clinical research ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...regulatory compliance, and medical affairs expertise across our global CMR organization. The ideal candidate will have a… more
- Insmed Incorporated (NJ)
- …relevant regulatory requirements for drug approval Significant experience in global regulatory submissions Extensive knowledge of and experience with CDISC ... patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …compliance activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality ... optimize, and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory compliance,… more
- Formation Bio (New York, NY)
- … GXP/PV/CSV regulations and guidance. Ensuring preparedness for pre-approval and routine regulatory inspections conducted by global Regulatory Health ... experience with oversight of CSV is preferred. Strong working knowledge of global regulatory requirements, including GMP, GCP, and ICH guidelines. Expertise… more
- Merck & Co. (Boston, MA)
- …to ensure seamless translation from bench to bedside.Provide strategic input into global regulatory interactions, including specification setting and response to ... division manages key stages in drug development, collaborating with scientific, regulatory , and statistical teams to turn preclinical discoveries into clinical-ready… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …understanding of professional working environment as well as Quality Assurance and global regulatory requirements such that identification of risks is recognized ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items… more
- Merck & Co. (Rahway, NJ)
- …potential risk, generate gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for medical devices and combination products ... leadership skills to shape the technical capabilities and strategic direction for a global , cross-modality technical team. The Director will lead a team of technical… more
- Aequor (San Diego, CA)
- …and infrastructure qualification documentation and protocols, in accordance with global regulatory guidelines.Provide input into developing scope, actions, ... CSV subject matter expert and provide guidance on and interpretation of global GxP guidance and regulations of computerized systems, electronic records, electronic… more
- Merck & Co. (Rahway, NJ)
- …potential risk, generate gap analysis and mitigation strategiesIn-depth knowledge of global regulatory requirements for distribution including good distribution ... along with leadership skills to shape the technical capabilities lead a global , cross-modality technical team.The Associate Director will lead a team of technical… more
- Merck & Co. (Rahway, NJ)
- …risk, generate gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for distribution including good distribution ... leadership skills to shape the technical capabilities and strategic direction for a global , cross-modality technical team. The Director will lead a team of technical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and clinical trials complaint handling Ensures local/affiliate SDEA templates meet both Global and local regulatory requirements Supports audit and inspection ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...QA, NNI Legal, NNI Compliance, NNI Commercial, NNI Finance, Global Business Services (GBS), PV & GDP Auditor(s) as… more
- Merck & Co. (Rahway, NJ)
- …potential risk, generate gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for medical devices and combination products ... leadership skills to shape the technical capabilities and strategic direction for a global , cross-modality technical team. The Director will lead a team of technical… more
- Merck & Co. (Rahway, NJ)
- …potential risk, generate gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for medical devices and combination products ... skills to shape the technical capabilities and strategic direction for a global , cross-modality technical team. As an individual contributor, the associate director… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical affairs, or clinical development. requiredMust possess a solid understanding of global health authority regulatory requirements particularly in the areas ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (North Wales, PA)
- …compliance of the teams executing processes according to SOP to meet global regulatory and internal standards. Champions Continuous ImprovementLeads or supports ... is responsible for the formulation and execution of automation strategy in Global Clinical Trial Operations and all the support activities within their functional… more
- Eisai, Inc (Nutley, NJ)
- …experience as a Clinical Pharmacology Project Lead.A thorough understanding of global regulatory requirements on the Clinical Pharmacology and Translational ... to safety and efficacy.Contributes to Clinical Pharmacology expertise and content to regulatory documents (eg briefing books, INDs, NDAs etc.) and represent Clinical… more
