- Merck & Co. (Rahway, NJ)
- …to Executive Director or Associate Vice President, General MedicineDevelops worldwide product regulatory strategy to optimize label and obtain shortest ... final approval for all submissions and associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and regulatory … more
- Aequor (Thousand Oaks, CA)
- …and submission, advisory committee meeting preparations) o Create and maintain product regulatory history documents through IMR and appropriately archive ... registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and maintain Quality Management System and GMP Compliance Programs to assure product quality, integrity and compliance with regulatory guidelines and ... planning and supply forecast of commercial and IMP drug product . Supports regulatory inspection and its readiness. Works diligently with CMO representatives… more
- Aequor (Thousand Oaks, CA)
- …role to be?The Associate Regulatory Affairs (CMC) role is an entry level regulatory position that provides varying levels of product support to the ... to speak to why they want to work in regulatory affairs/ CMC. This was a big miss on...development. Support may include organizing, managing and executing on regulatory CMC projects in support of regulatory … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Profile (TPP) Development Support: Provide support for clinical trial strategy, regulatory development, and the development of Target Product Profiles (TPPs) ... to understand clinical data / patient outcomes, identify market opportunities, address regulatory requirements, and help to shape product development strategies … more
- Merck & Co. (North Wales, PA)
- …the promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launchUnderstanding of the ... all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to...(aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of… more
- Merck & Co. (Rahway, NJ)
- …and supporting regulatory filings.Build deep fundamental knowledge around the drug product to ensure completion of key milestones and laboratory / regulatory ... written communication skillsThe candidate should have a strong track record in product development/ regulatory filing/ drug delivery/ complex formulation and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This ... and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU SmPC, PIL,… more
- Tris Pharma (Monmouth Junction, NJ)
- …of clinical study conduct; Collaborates closely with internal stakeholders, (ie Regulatory Affairs, Product Development, Research and Development (R&D), Quality ... trial data and translates data into actionable plans at product levelContributes to Medical aspects of Regulatory ...at product levelContributes to Medical aspects of Regulatory issues related to development compounds or marketed products… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … product team meetings (development and marketed products); provide regulatory support and guidance and manage day-to-day regulatory activities.Collaborate ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Merck & Co. (North Wales, PA)
- …curious, join us-and start making your impact today. -Overview: The Regulatory Digital Health (RDH) department engages with enterprise leaders across the ... support OPS (Operations, Processes, and Strategic Execution) Policy Execution and the regulatory strategy of digital health tools (DHTs) and software medical devices… more
- Genmab (Trenton, NJ)
- …as marketing applications (eg, BLAs/MAAs). Evaluate competitive landscape and various regulatory mechanisms that allow optimization of product development (eg, ... passionate leader to be a part of our Global Regulatory Affairs (GRA) organization. In this role, you will...strategies at various stages of development (in line with Product Development Plan). Represent GRA in Compound Development Teams… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Artificial Intelligence (AI) Product Lead is a strategic role focused on defining and driving the use of AI ... use cases, managing pilot projects, establishing best practices, and crafting comprehensive product narratives. The leader in this role will also lead the… more
- Aequor (Thousand Oaks, CA)
- …Let's change the world! In this vital role, you will provide support to the Product Quality (PQ) organization as a subject matter expert of clinical and commercial ... product stability studies and GMP data management. In this...diverse functional areas including Supply Chain, Manufacturing, Quality Control, Regulatory , Quality Assurance, Quality Engineering, International Quality and Process… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ad hoc member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) ... (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory ...on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an… more
- Novo Nordisk Inc. (Boulder, CO)
- …development. Are you ready to maximize your potential with us? The Position The Product QA Specialist will be responsible for the review and approval of GMP clinical ... initiate necessary records according to company procedures Collect and maintain monthly product quality metrics data for QA Management Maintain systems used for… more
- Merck & Co. (North Wales, PA)
- …specifically in Digital Quality and Labs, Digital Quality Operations, Content Management Product Line Team. This team is responsible for designing, implementing, and ... QMS processes, including Content Management and Digital Validation. The Digital Validation Product Analyst will provide close support for the Digital Validation … more
- USAA (Alhambra, CA)
- …Come be a part of what makes us so special! As a dedicated Bank Agile Product Owner Senior for Disputes, you will work directly with the Bank agile team to ... to decisions and impediment removal including strategic priorities and funding allocation. Sets product / value stream direction and ensures it is aligned with key… more
- Genmab (Princeton, NJ)
- …new capabilities and enhancement / continuous improvement of processes, leveraging Product Oriented Delivery and Agile methodology Leadership of resources and ... Products Maintaining a compliant state in Genmab's SOX and GxP regulatory environments Work effectively in a Software development environment leveraging agile… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Risk Management Plan(s) (RMPs)Collaborates with PSL(s) and cross-functional team for assigned product (s) to author or contribute to regulatory authority requests ... proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in… more
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