Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing
3 meses atrás
.Job Description The Position The Associate Director (Associate Principal Scientist), Organon Manufacturing & Supply (OMS), Chemistry, Manufacturing & Controls (CMC), Network Project & Resource Management will provide regulatory CMC support for Organon Network Projects. This position will lead the preparation and submission of CMC dossiers for assigned Network Projects. The individual may also support project team goals and organizational initiatives on an as-needed basis. This will include oversight and monitoring of assigned CMC project timelines. This position will work alongside CMC Product Leaders, OMS Network Teams, and CMC partners to ensure progress towards project goals. The position will also be responsible for providing CMC support to the Network Project CMC Lead in making strategies for projects. This position will also be responsible for working with outsourced support of Network activities in alignment with the OMS CMC outsource strategy. This includes proactive collaboration with external partners to monitor, report, and act on delivery performance and quality of deliverables. The incumbent requires in-depth knowledge and skills in CMC strategy, with strong capability in project management. The successful candidate requires a strong track record of demonstrated knowledge of CMC life cycle management and eCTD. Responsibilities Managing processes and connections between the external partners and the various stakeholders within CMC. Serves as the CMC Lead for assigned Global Network projects and is accountable for the delivery of all regulatory milestones. Responsible for overseeing preparation and submission of Global CMC dossiers for assigned Network projects. Cultivate and foster collaborative relationships with internal and external partners to drive on-time, high-quality delivery of business commitments. Actively monitor, facilitate, report, and communicate progress against agreed timelines and proactively resolve issues to enable delivery of high-quality, on-time submission information. Escalate potential delays or performance issues in a timely manner to impacted, cross-functional stakeholders. Manage communication and change management within the internal organization. Provide CMC support for Legal Entity Change (LEC) project. Required Education, Experience and Skills Bachelor's degree in a science, engineering, or a related field such as Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, or Molecular Biology. Or advanced degree (MS, MBA, Ph.D., PharmD) with a minimum of 4 years of relevant experience including biological/pharmaceutical research, manufacturing, testing, or a related field. Minimum of 7 years of relevant experience if holding a bachelor's degree. Strong negotiation, interpersonal, written/oral communication, and fluent in English language. Ability to lead by influence and work effectively in matrix organizational structures. Project Management skills
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Regulatory Affairs Chemistry Manufacturing Expert
4 semanas atrás
Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiroJob SummaryBiom?Rieux Bv seeks a highly skilled Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing to provide regulatory CMC support for Organon Network Projects. This position will lead the preparation and submission of CMC dossiers for assigned Network Projects.
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Lisboa, Lisboa, Portugal Organon Tempo inteiroJob DescriptionThe PositionThe Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing will provide regulatory support to ensure compliance with global regulations and standards. This includes preparing and submitting regulatory documents for assigned projects. The individual will lead the preparation of CMC dossiers and work alongside...
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Lisboa, Lisboa, Portugal Organón Tempo inteiroJob Description: We are seeking a highly skilled Associate Principal Scientist to join our Organon team in a Regulatory Affairs Chemistry Manufacturing role. The successful candidate will provide regulatory CMC support for Organon Network Projects, leading the preparation and submission of CMC dossiers for assigned Network Projects. They will also oversee...
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Lisboa, Portugal Organon Tempo inteiroPositionThe Associate Principal Scientist is responsible for facilitating and implementing Regulatory CMC strategies for assigned small molecule products supporting Site of Source Changes in accordance with global regulations and guidance's, and Company procedures. The Associate Principal Scientist is responsible for the preparation and review of...
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Lisboa, Portugal Organon Tempo inteiroPositionThe Associate Principal Scientist is responsible for facilitating and implementing Regulatory CMC strategies for assigned small molecule products supporting Site of Source Changes in accordance with global regulations and guidance's, and Company procedures. The Associate Principal Scientist is responsible for the preparation and review of regulatory...
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Lisboa, Portugal Organon Tempo inteiro.Position The Associate Principal Scientist is responsible for facilitating and implementing Regulatory CMC strategies for assigned small molecule products supporting Site of Source Changes in accordance with global regulations and guidance's, and Company procedures. The Associate Principal Scientist is responsible for the preparation and review of...
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Lisboa, Portugal Organon Tempo inteiro.PositionThe Associate Principal Scientist is responsible for facilitating and implementing Regulatory CMC strategies for assigned small molecule products supporting Site of Source Changes in accordance with global regulations and guidance's, and Company procedures. The Associate Principal Scientist is responsible for the preparation and review of regulatory...
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Lisboa, Portugal Biom?Rieux Bv Tempo inteiro.Job DescriptionAlthough one or more potential candidates for this position have been identified via internal succession planning, we will consider applications from any interested applicants.PositionThe Associate Principal Scientist is responsible for facilitating and implementing Regulatory CMC strategies for assigned small molecule products supporting...
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Lisboa, Portugal Biom?Rieux Bv Tempo inteiro.Job Description Although one or more potential candidates for this position have been identified via internal succession planning, we will consider applications from any interested applicants. Position The Associate Principal Scientist is responsible for facilitating and implementing Regulatory CMC strategies for assigned small molecule products supporting...
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Lisboa, Portugal Biom?Rieux Bv Tempo inteiro.Job DescriptionThe PositionThe Associate Director (Associate Principal Scientist), Organon Manufacturing & Supply (OMS), Chemistry, Manufacturing & Controls (CMC), Network Project & Resource Management will provide regulatory CMC support for Organon Network Projects. This position will lead the preparation and submission of CMC dossiers for assigned Network...
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Lisboa, Portugal bioM?rieux BV Tempo inteiroJob DescriptionAlthough one or more potential candidates for this position have been identified via internal succession planning, we will consider applications from any interested applicants.PositionThe Associate Principal Scientist is responsible for facilitating and implementing Regulatory CMC strategies for assigned small molecule products supporting...
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Lisboa, Portugal Biom?Rieux Bv Tempo inteiroJob DescriptionAlthough one or more potential candidates for this position have been identified via internal succession planning, we will consider applications from any interested applicants. Position The Associate Principal Scientist is responsible for facilitating and implementing Regulatory CMC strategies for assigned small molecule products supporting...
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Lisboa, Portugal Biom?Rieux Bv Tempo inteiroJob DescriptionAlthough one or more potential candidates for this position have been identified via internal succession planning, we will consider applications from any interested applicants.PositionThe Associate Principal Scientist is responsible for facilitating and implementing Regulatory CMC strategies for assigned small molecule products supporting Site...
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Lisboa, Portugal Organón Tempo inteiro.Job DescriptionThe PositionThe Associate Director (Associate Principal Scientist), Organon Manufacturing & Supply (OMS), Chemistry, Manufacturing & Controls (CMC), Network Project & Resource Management will provide regulatory CMC support for Organon Network Projects. This position will lead the preparation and submission of CMC dossiers for assigned Network...
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Associate Principal Scientist, Regulatory Affairs
1 semana atrás
Lisboa, Portugal Organon Tempo inteiro**Position** The Associate Principal Scientist is responsible for facilitating and implementing Regulatory CMC strategies for assigned small molecule products supporting Site of Source Changes in accordance with global regulations and guidance's, and Company procedures. The Associate Principal Scientist is responsible for the preparation and review of...
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Lisboa, Portugal Organón Tempo inteiro.Job Description The Position The Associate Director (Associate Principal Scientist), Organon Manufacturing & Supply (OMS), Chemistry, Manufacturing & Controls (CMC), Network Project & Resource Management will provide regulatory CMC support for Organon Network Projects. This position will lead the preparation and submission of CMC dossiers for assigned...
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Lisboa, Portugal Organón Tempo inteiroJob DescriptionThe PositionThe Associate Director (Associate Principal Scientist), Organon Manufacturing & Supply (OMS), Chemistry, Manufacturing & Controls (CMC), Network Project & Resource Management will provide regulatory CMC support for Organon Network Projects. This position will lead the preparation and submission of CMC dossiers for assigned Network...
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Lisboa, Portugal Biom?Rieux Bv Tempo inteiroJob DescriptionThe PositionThe Associate Director (Associate Principal Scientist), Organon Manufacturing & Supply (OMS), Chemistry, Manufacturing & Controls (CMC), Network Project & Resource Management will provide regulatory CMC support for Organon Network Projects. This position will lead the preparation and submission of CMC dossiers for assigned Network...
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Lisboa, Portugal Biom?Rieux Bv Tempo inteiroJob DescriptionThe Position The Associate Director (Associate Principal Scientist), Organon Manufacturing & Supply (OMS), Chemistry, Manufacturing & Controls (CMC), Network Project & Resource Management will provide regulatory CMC support for Organon Network Projects. This position will lead the preparation and submission of CMC dossiers for assigned Network...
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Lisboa, Portugal organón Tempo inteiroJob DescriptionThe PositionThe Associate Director (Associate Principal Scientist), Organon Manufacturing & Supply (OMS), Chemistry, Manufacturing & Controls (CMC), Network Project & Resource Management will provide regulatory CMC support for Organon Network Projects. This position will lead the preparation and submission of CMC dossiers for assigned Network...
