- Twist BioScience (South San Francisco, CA)
- …to rapidly develop innovative gene synthesis solutions and support broader product adoptionFollow regulatory and ISO 13485 requirementsWhat You'll Bring ... The Product Manager will develop multi-generational product strategies and guide planning for future positioning, growth, and development of disruptive… more
- Insmed Incorporated (NJ)
- …global regulatory strategies and plans to enable efficient, competitive product development for assigned programs. This role will provide regulatory ... pre-clinical, and lifecycle management activities for assigned programsIdentify and assess regulatory risks associated with product development and define… more
- Insmed Incorporated (NJ)
- …you will ensure high-quality, timely, and compliant preparation and delivery of regulatory documentation throughout product lifecycles. You will work closely ... in. Are you?About the Role:We're looking for a Manager, Regulatory Affairs, Tactical Implementation, on the Regulatory ...Manager, Regulatory Affairs, Tactical Implementation, on the Regulatory Affairs team to help us expand what's possible… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …team, Commercial Operations, Commercial, NNI IT and Telephony, Medical Information, Product Safety, Regulatory , Quality, Legal, Privacy and Finance. External ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Formation Bio (New York, NY)
- …coordinating departmental and cross-functional support.Responsibilities Designs and implements regulatory strategies to obtain, maintain product investigative ... knowledge towards development of strategic and tactical plans. Identifies and assesses regulatory risks associated with product development for Formation Bio's… 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 ... ob description This position will be responsible for leading and implementing medical device and combination product design controls for both new products and inline… 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
- Twist BioScience (South San Francisco, CA)
- …System (ISMS) standards in the execution of their daily activities and ensuring product or service meets regulatory requirements, customer requirements and the ... field-based sales team. The position will specifically support Twist's current product lines consisting of synthetic genes, oligo pools, and DNA libraries.What… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are looking for a Senior Specialist Regulatory Affairs CMC (m/w/d) to join our team in the innovative research location in Schwabenheim (near ... and maintenance of standard processes and systems to maintain regulatory information to support regulatory compliance. This...US or EU to ensure compliance Participate on new product development teams as well as other types of… more
- Eisai, Inc (Nutley, NJ)
- …with business objectives and comply with local regulations.Develop and implement regulatory strategies for market entry, product registrations, and lifecycle ... regulatory representative on the project team throughout the product lifecycle.Assists, as needed, interactions and negotiations with health authorities. May… more
- Insmed Incorporated (NJ)
- …you?About the Role:We are seeking a highly experienced and visionary Vice President, Product Development - CMC, Small Molecules, to help us expand what's possible ... pipeline. As a senior leader, you will oversee drug substance and drug product development, analytical development, and combination product development. To be… more
- Insmed Incorporated (NJ)
- …you?About the Role:We are seeking a highly experienced and visionary Vice President, Product Development - CMC, Gene Therapy and Large Molecules, to help us expand ... large molecules pipeline from preclinical through clinical development and regulatory approvals. In this role you will be a...therapies to patients.What You'll Do: As the Vice President, Product Development - CMC, Gene Therapy and Large Molecules,… more
- Bayer (Myerstown, PA)
- …approval of projects (ie Development Plans, Development Reports and Technical Regulatory Documentation).Attend product research to understand consumer feedback ... development of project risk assessment, technical success criteria, Target Product Profile (TPP), and contingency plansfor development activities. Lead development… more
- Repligen (Waltham, MA)
- …and driven IT Business Partner to represent our Manufacturing, Quality, Supply Chain, Product Development, and R&D organizations. As a Director of IT, you will play ... efficiency, and enabling innovation across the bioprocessing manufacturing and product development lifecycle.This position requires strong collaboration with business… more
- Eisai, Inc (NJ)
- …& Cross-functional Influence, Critical Thinking & Business Agility, Industry/ Regulatory Knowledge, Mentoring/ People Development, Product Training Skills, ... If this is your profile, we want to hear from you. The Manager Product training is responsible for the following:- Developing and implementing training programs for… more
- Eisai, Inc (Bethesda, OH)
- …environments and requirementsSolid knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines.Strong ... for the leadership and oversight of the Labeling function within Global Regulatory Services and Operations (GRSO). This position will manage labeling operations and… more
- Insmed Incorporated (NJ)
- …appropriate risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develop/provide input to product Benefit-Risk ... years of Clinical Patient Care experience strongly preferred.A background in providing product defense before a national or international regulatory authority is… more
- Formation Bio (New York, NY)
- …the appropriate identification, evaluation, and management of risks associated with product quality. Build strong relationships with regulatory agencies and ... implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and industry best practices to support drug development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, ... Clinical Safety, will lead the development and implementation of integrated project/ product risk management strategies aimed at achieving the optimum benefit-risk… more
- Formation Bio (New York, NY)
- …of technical expertise, strategic thinking, leadership capabilities, and a strong regulatory and industry knowledge base in pharmaceutical sciences or engineering to ... drive successful drug product development and manufacturing operations.Responsibilities Technical Leadership: Provide technical leadership for development and… more
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