- Merck & Co. (Rahway, NJ)
- …collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.Provide Voice of Manufacturing input to ... Job DescriptionJob Summary: The Director, Combination Product Commercialization is a key leadership role within the Device Development and Technology Organization.… more
- Merck & Co. (Rahway, NJ)
- …with internal and external stakeholders such as drug substance, drug product , device, analytical, regulatory , project leaders, manufacturing sites, and ... Job DescriptionReporting to the leader of Packaging and Combination Product Commercialization, the Director of Sterile Product Packaging Development is… more
- Insmed Incorporated (San Diego, CA)
- …global regulatory strategy plans to facilitate efficient and driven product developmentMonitor the evolving regulatory competitive landscape to identify ... area (Master's/PhD/PharmD) preferred. RAC certification desired10+ years of experience in Regulatory Affairs, and product development experience within the… more
- Merck & Co. (Rahway, NJ)
- …robust solutions and approaches are developed by working teams supporting the product .Compile with our company's Global and regulatory requirements and execute ... Process, Manufacturing Scale-Up, Process Improvements, Product Commercialization, Product Lifecycle, Product Management, Regulatory Requirements,… more
- Merck & Co. (Rahway, NJ)
- …Negotiation, Post Marketing Surveillance, Product Lifecycle Management (PLM), Product Upgrades, Regulatory Compliance, Scientific Leadership {+ 1 ... medical device engineering, particularly in the design, manufacturing, and regulatory aspects of Autoinjectors and combination products.Primary Responsibilities:Technical Strategic… more
- Merck & Co. (San Diego, CA)
- …point of contact, with significant experience, the Liaison provides strategic regulatory oversight to accelerate approvals and optimize product labeling.This ... labels and achieving timely regulatory approvals.Serve as an experienced worldwide regulatory representative on Asset or Product Development Teams and act as… more
- Aequor (South San Francisco, CA)
- …tracking, and audit readiness. You will work cross-functionally with content strategists, regulatory affairs, product owners, and engineering teams to ensure ... tagging strategy to power personalization, AI/ML classification, and dashboard reporting. Regulatory Support & Audit Readiness Ensure metadata compliance with … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …issues or issues resulting in the delay of investigation closure and product release.Support regulatory inspections and audits by ensuring inspection readiness ... occur in the production of a personalized cell therapy product in a sterile GMP environment. The ideal candidate...and serving as an SME during the execution of regulatory inspections and audits as needed.Support compliance activities for… more
- Merck & Co. (Durham, NC)
- …Process Improvement Projects, Process Improvements, Production Planning, Production Scheduling, Product Offerings, Project Management, Regulatory Submissions {+ ... functions necessary to allow proper accountability and traceability of product . Maintains, inventories and transports all required equipment, materials, supplies… more
- Merck & Co. (Rahway, NJ)
- …- Accelerated timelines for site, filing, and launch readiness- - Improved access to product and process data - Streamlined transfer of process and product ... key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed...a frictionless flow of data from source systems to regulatory documentation .-- - Under the guidance of dCMC… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders Job Summary: The Head of Regulatory Advertising and Promotion (RAAP) will lead and oversee all regulatory ... commercial goals. This role also involves managing a team of regulatory professionals, fostering collaboration across departments, and maintaining a proactive… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPrincipal Scientist - Mixed Modalities, Sterile Product Development The Mixed Modalities team within Sterile Product Development is responsible ... development candidates, including screening and development of robust drug product composition, scalable process, primary packaging, compatibility characterization for… more
- Merck & Co. (Rahway, NJ)
- …Support iterative updates to data models as new sources are connected or regulatory requirements evolve.Data Product Support and Evolution: Develop and maintain ... data products that enable auto-generation of regulatory filing content. Collaborate with product owners and technical teams to gather requirements, test new… more
- Merck & Co. (Rahway, NJ)
- …responses regulatory agency questions and pre-approval inspections during a product development and life cycle managementDevelop and execute strategic plans for ... Delivery, Injection Moldings, Management Process, Manufacturing Compliance, Medical Devices, Product Commercialization, Quality Management System Improvement, Regulatory … more
- Merck & Co. (Durham, NC)
- …verbal and written communicationDeep scientific understanding of vaccine and/or biologic product process or analytics, and integration with regulatory /GMP ... Job DescriptionVaccines tech product leadership (V-TPL) within large molecule science and...strong and trusting relationships with site technical operations, quality, regulatory , stability, and other stakeholders to ensure effective communication… more
- Merck & Co. (Boston, MA)
- …and Development Sciences (RaDS) value team in R&D IT brings together product management, engineering, and data science expertise. We enable data, technology and ... change the course of human health. In the RaDS value team, the Product organization is responsible for implementing capabilities and associated services to advance… more
- Aequor (Golden Valley, MN)
- …Science, Nutrition, Labeling or related field 1-3&plus years of experience in regulatory , quality and/or product commercialization Basic understanding of ... in the US within the North America Labeling and Regulatory Compliance team but partners globally to support business...certifiers as required. Partner with Labeling to guide the product development process (new and reformulated products) to ensure… more
- Merck & Co. (North Wales, PA)
- …Integration, Operational Excellence, Oral Communications, Pharmaceutical Management, Product Registrations, Professional Networking, Project Management, ... including pipeline candidates and licensed products. The Section Head manages Product Development Team (PDT) leaders and clinical directors responsible for the… more
- Merck & Co. (Durham, NC)
- Job DescriptionVaccines tech product leadership (V-TPL) within large molecule science and technology (LMS&T) is seeking a highly motivated individual for the role of ... science and technology for commercial vaccine products including Drug Substance, Drug Product , and Analytics.-We are seeking a Sr. Specialist to join our Live… more
- Eisai, Inc (Nutley, NJ)
- …of brand plansStrong communication and presentation skillsUnderstanding of legal and regulatory issues impacting pharmaceutical product marketing as well as ... that can help simplify the patient journeyIdentify and ensure training ( product , disease state and compliance training) for promotional speakers and related… more
