- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders.Summary This role is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through direct and indirect line ... corporate initiatives, ensuring that DS is prepared to meet new or proposed global regulatory requirements and that DS has a voice in defining new requirements.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... RA strategy into a global strategy.Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and other governance bodies.Serve as a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference?The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational ... medicines. You will lead a global regulatory team to develop and execute regulatory strategies for high impact projects while working with decision-makers… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities.SummaryThis position leads the Global Regulatory Affairs (GRA) Global Labeling function, ... scientific, regulatory , and business perspectives to ensure compliance with evolving global regulatory requirements and with company objectives. The Head of… more
- Merck & Co. (North Wales, PA)
- …Document for projects of increasing complexity.Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change ... for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes defining regulatory data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in all regions. The Director of Dossier Planning will report to Head of Global Regulatory Operations and be an active participant on the Regulatory ... centered around rare diseases and immune disorders.Summary The Director, Head of Global Dossier Planning, Regulatory Operations is responsible for leading the… more
- Merck & Co. (Rahway, NJ)
- …formulations, and devices. The Executive Director, as a senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and Controls ... GRACS CMC Leadership Team. Their role is pivotal in fostering alignment and global execution across Regulatory Affairs, R&D, Manufacturing, and our Commercial… more
- Merck & Co. (North Wales, PA)
- … Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned projects in the Vaccines and ... with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more of our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global ... global health authority query (HAQ) tracker and archiving regulatory correspondencesSupport DSUR/PBRER preparation by attending Kick-off Meeting, coordinating and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, ... CDx RA Policy and Intelligence: Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these changesAssessing… more
- Merck & Co. (North Wales, PA)
- …corporate standards and policies and business objectives.Actively- participate in labeling and global regulatory team meetings to ensure support for anticipated ... all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to...to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its… more
- Aequor (Thousand Oaks, CA)
- …and coordinate the preparation of regulatory submission documents that comply with global regulatory standards. Write or lead all aspects of the writing of ... FULLY REMOTE final BR - / hour Regulatory Writing Manager In this vital role you...All Studies, briefing documents, and safety narratives Write other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough… more
- Aequor (Thousand Oaks, CA)
- …license applications Serve as functional area lead on product teams (eg, Global Regulatory Team, Evidence Generation Team, Global Safety ... Team, Label Working Group) Provide functional area input for Global Regulatory Plan and team goals Supervise the work of contract and freelance writers and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a sound, overarching and competitive, asset strategy and execution to ultimately achieve global regulatory filings and ensure wide access of the compound. That ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- …commercial input on such activities as: target product profile development, global regulatory filing strategy, labeling, launch readiness reviews, organized ... the value chain: basic science and biology, clinical development and innovation, regulatory processes, global launch dynamics, access and reimbursement and… more
- Merck & Co. (Rahway, NJ)
- …to lead / co-lead activities as belowTarget product profile development, global regulatory filing strategy, launch readiness reviews, organized customer ... Job DescriptionWe are recruiting for a Director Global Oncology Marketing for a new asset in...executionL3 Next development and execution including omnichannel customer engagement Global Launch Readiness leadership and launch execution Region &… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …GxP and Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes ... a risk-based framework (Computer Software Assurance (CSA)) that is compliant with global regulatory expectations and business expectations to execute … more
- Merck & Co. (Rahway, NJ)
- …questions for optimizing model-based development-Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... cycle time, cost/size and number of trials, implementation of tools and regulatory framework for rapid approvals and driving Go/No Go decisions on programsServing… more
