- 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
- 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
- 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)
- …the respective marketing teams within the organization along with sales, product development, regulatory affairs, customer service, and other cross-functional ... of industry trends, competitor activities, and customer needs to inform product development and marketing strategies Interpret internal and external business… 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
- USAA (San Antonio, TX)
- …of change initiatives resulting from updates to accounting requirements, regulatory requirements, product offerings, systems, and organizational structure. ... special and impactful. The Opportunity As a dedicated Financial Regulatory Reporting Senior , you will serve as a...the preparation, review, and analysis of reports compiled for regulatory agencies to include the FR Y-9C, FR Y-9LP,… 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
- 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
- Merck & Co. (Rahway, NJ)
- …degree is preferred.Leadership experience with working knowledge of device, biologic/drug product , and process development including regulatory submission and ... Technical and Engineering Lead (Associate Director Equivalent) Our company's Device Product & Process Development (DPPD) Team designs, develops, and commercializes… more
- Larimar Therapeutics (Philadelphia, PA)
- …its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (CTI-1601), is a subcutaneously administered, recombinant fusion ... consultants have significant expertise in discovery, non-clinical and clinical development, regulatory affairs, manufacturing and CMC. Our company's strategy is to… 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
- Merck & Co. (Rahway, NJ)
- …enable innovation.We are looking for an experienced professional with a strong IT - Product Management background to help us shape the vision and strategy of our ... software products in the clinical domain.The Technical Product Manager in this role should be able to...solutions that improve how we run clinical trials and regulatory submission for our patients, partners, and colleagues.As a… more
- Eisai, Inc (Durham, NC)
- …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
- 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
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