- Merck & Co. (Upper Gwynedd, PA)
- …risk mitigation measures.-Lead development and execution of global product and project regulatory strategy (ies) by ensuring robust assessment of global ... risks.Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects.Provide regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...regulatory expertise on IVDR. This person will develop regulatory strategy and provide input on IVDR… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience and 4+ ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in portfolio strategy , strategic planning or related roles within the pharmaceutical industry or a related industry required Strong knowledge of the ... center, powered by insight and foresight. We develop an end-to-end approach to strategy , focusing on every touchpoint that impacts our customers. We leverage data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems while ensuring alignment with the Global Digital Transformation (DX) strategy , regulatory compliance framework, and overall quality assurance standards. ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… more
- MMS Holdings Inc. (Canton, MI)
- …related experience, Masters or PhD preferred. Minimum of 10 years experience in Regulatory Affairs or Strategy or similar field required, including experience ... culture and industry best employee retention rate. We support the pharmaceutical , biotech, and medical device industries with our proven, scientific approach… more
- Katalyst HealthCares and Life Sciences (Trenton, NJ)
- Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing ... drug development processes and post-approval requirements. Experience in developing CMC regulatory strategy . Experience in project management. Have a… more
- The Fountain Group (Cambridge, MA)
- … Regulatory CMC expertise into the development and implementation of the global regulatory strategy , operations, and planning for the CMC aspects of assigned ... a national staffing firm and are currently seeking a Regulatory Affairs Manager III for a prominent Pharmaceutical... Regulatory Affairs Manager III for a prominent Pharmaceutical client of ours. This position is Remote. Details… more
- Merck & Co. (Rahway, NJ)
- …should have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non-clinical, ... Leadership, Pharmaceutical Development, Pharmaceutical Formulations, Pharmaceutical Sciences, Product Development, Regulatory CMC, Statistical Design… more
- Accede Solutions, Inc. (Lexington, MA)
- Hybrid Role The Associate Director of Regulatory Affairs CMC will support development CMC team activities for an emerging portfolio of biologics products. This ... business and with external partners to develop submission content and strategy . Responsibilities: Ensures high-quality and on-time submissions, including for INDs,… more
- Omni Inclusive (Trenton, NJ)
- …Key Responsibilities/Abilities *Independently manages project scope, timelines, goals, strategy , and communication for projects *Clearly and efficiently articulates ... a strong background on critical and diverse topics related to the pharmaceutical industry (issues, trends) and be able to effectively identify opportunities and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... and immune disorders. Job Summary: Position sets the vision, direction, and strategy for Data Management globally and ensures execution of the data management… more
- Eisai, Inc (Nutley, NJ)
- …relations, government price reporting, patient support, as well as other pharmaceutical regulatory counseling. Essential Functions: Provides proactive and ... of assigned business clients.Helps drive the implementation of legal strategy and policies.Develops training content as needed on legal...standing of a state bar. Strong knowledge of FDA regulatory and fraud and abuse laws and/or pharmaceutical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …by overseeing 5D efforts including Data, Diagnostics, Drug, Device, and Digital strategy and execution for relevant TAs, aligned closely with Rare Disease ... development of the go-to-market plan for the launch of a customer-centric strategy and initiatives that will enable awareness, early diagnosis, differentiation and… more
- Eisai, Inc (Nutley, NJ)
- …orientation to identify breakthrough opportunities.Comprehensive understanding of legal and regulatory issues impacting pharmaceutical product marketing as well ... and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong… more
- Merck & Co. (Boston, MA)
- …Collaboration, Modeling Software, Multidisciplinary Collaboration, NONMEM, Pharmaceutical Development, Pharmaceutical Sciences, Pharmacodynamics, ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function within R&D. Reviews and provides guidance to RBQM… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the pharmaceutical industry required Proven knowledge of the pharmaceutical industry, including medical, regulatory , clinical processes and market ... center, powered by insight and foresight. We develop an end-to-end approach to strategy , focusing on every touchpoint that impacts our customers. We leverage data… more
- Merck & Co. (Rahway, NJ)
- …and transfer using immunoassay techniques.Extensive knowledge and experience with regulatory guidance and industrial standards of control strategy ... working closely with the group Director to define group strategy and to lead a team of scientists in...a minimum of 8 years of experience in the pharmaceutical industry, MS in analytical chemistry/biochemistry or related field… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a marketing role within the pharmaceutical industry Experience in pharmaceutical industry/life science brand marketing strategy and planning; experience ... center, powered by insight and foresight. We develop an end-to-end approach to strategy , focusing on every touchpoint that impacts our customers. We leverage data… more
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