- Insmed Incorporated (NJ)
- …of science, we're in. Are you?About the Role:We're looking for a Manager, Regulatory Affairs, Tactical Implementation, on the Regulatory Affairs team to help ... for patients with serious diseases. Reporting to the Associate Director, Regulatory Affairs, Tactical Implementation, you'll have a critical role in hands-on… more
- Merck & Co. (Rahway, NJ)
- …and supply. A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a ... frictionless flow of data from source systems to regulatory documentation.- - - Under the guidance of dCMC... documentation.- - - Under the guidance of dCMC Regulatory Authoring Leadership, the Senior Specialist, Regulatory … more
- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:We're looking for an Associate, Regulatory Operations on the Regulatory team to help us expand what's ... for patients with serious diseases. Reporting to the Executive Director, Regulatory Operations, you'll be responsible for the publishing, management, and submission… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. The Director, Global Regulatory , Growth Markets will be responsible for providing regulatory leadership and ... This role will focus on the development and execution of regulatory strategies for products under development, post-approval activities, and life-cycle management,… more
- Insmed Incorporated (NJ)
- …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...product development for assigned programs. This role will provide regulatory input to global cross-functional project teams throughout product… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing and directing the regional ... regulatory strategy, objectives, policies, and programs pertaining to developing...marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global registration and life… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. We are currently seeking a Global Regulatory Affairs Labeling Operations Intern for Summer 2026. This full-time position works ... Summary:We are seeking a detail-oriented and tech-savvy student to join our Global Regulatory Affairs Labeling Operations team as an intern.The Global Regulatory … more
- Eckert & Ziegler Isotope Products, Inc. (Valencia, CA)
- Quality Assurance & Regulatory Manager Valencia & Burbank, CA Company Benefits 100% employer paid medical and dental 401(k) matching contribution Generous PTO and ... & Ziegler Isotope Products seeks a Quality Assurance & Regulatory Manager to join our team. The Quality Assurance...Manager to join our team. The Quality Assurance and Regulatory Manager supports the Director of Quality Operations in… more
- Larimar Therapeutics (Philadelphia, PA)
- …consultants have significant expertise in discovery, non-clinical and clinical development, regulatory affairs, manufacturing and CMC. Our company's strategy is to ... day - we welcome you! Position Summary: Larimar is seeking a CMC Regulatory Affairs Director to provide professional experience and leadership supporting the global… more
- Unknown (Boston, MA)
- …collaborate cross-functionally with internal teams to ensure alignment of CMC regulatory strategies with overall development plans and corporate objectives. They ... will stay current on regulatory guidelines and requirements, providing expertise and guidance to...for CMC development teams. The Director will also lead regulatory intelligence activities, monitoring changes in regulations and guidelines… more
- Outlier AI (Philadelphia, PA)
- …Outlier is committed to improving the intelligence & safety of AI models. Owned and operated by Scale AI , we've recently been featured in Forbes for partnering ... experts with top AI labs to provide the high quality data for LLMs. We believe AI can only perform as well as the data it's trained on. That's why we work with contributors from all over the world , who help improve AI models by providing expert human feedback… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... projects in Late Development Statistics.Lead the interaction with Clinical, Regulatory , Statistical Programming, Data Management, and other Scientists from our… more
- Eisai, Inc (Boston, MA)
- …and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and standards. This ... vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate with the Heads of… more
- Eisai, Inc (Durham, NC)
- …for the leadership and oversight of the Labeling function within Global Regulatory Services and Operations (GRSO). This position will manage labeling operations and ... actively contribute to the development and implementation of regulatory labeling strategy and documentation for marketed products and products in development. This… more
- Merck & Co. (Rahway, NJ)
- …business objectives of the brand while ensuring adherence to internal processes and regulatory guidelines.- To prepare for these launches, we are looking for an ... accountable, global point of contact on each.- Interacting with internal marketing, regulatory , and trademark legal colleagues and third- party vendors, the AD will… more
- Merck & Co. (Rahway, NJ)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems...industry experience at least 6 of those in a regulatory and/or compliance area and experience with technical systems… more
- Insmed Incorporated (NJ)
- …completed on time and in accordance with all relevant company and regulatory policies and procedures. In addition, the Senior Director will be responsible, ... appropriate risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develop/provide input to product Benefit-Risk Assessments, Company… more
- Merck & Co. (Rahway, NJ)
- …products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance. The role will ... process inefficiencies using operational excellence tools and ensuring alignment with global regulatory requirements (eg, FDA 21 CFR Part 820, ISO 13485, ISO 14971).… more
- Eisai, Inc (Nutley, NJ)
- …optimize cost, enhance vendor performance, and mitigate operational and regulatory risks. The Senior Director oversees vendor qualification, governance frameworks, ... across the organization. Collaboration is central, working closely with Finance, Legal, Regulatory & Compliance, IT Security, and Clinical teams to align outsourcing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …global quality organization to ensure harmonization, alignment and execution of regulatory guidelines across all manufacturing areas, supporting both clinical and ... initiatives, such as inspection readiness, metrics implementation and review, overall regulatory compliance and implementation programs, and others as required. This… more
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