Associate Principal Scientist, Regulatory Affairs
2 meses atrás
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 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 in achieving project goals. The position will also be responsible for providing CMC support to the Network Project CMC Lead for project strategy.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.ResponsibilitiesManaging processes and connections between external partners and various stakeholders within CMC.Serves as the CMC Lead for assigned Global Network projects and be 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 SkillsBachelor's degree in a science, engineering, or a related field - Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology.Or Biochemistry - minimum 7 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field.Or advanced degree (MS, MBA, Ph.D., PharmD) - minimum 4 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field.Strong negotiation, interpersonal, written/oral communication skills and fluency in English.Ability to lead by influence and work effectively in matrix organizational structures.Project Management.Good understanding of change management projects.Preferred Education, Experience and SkillsDegree in pharmacy, biopharmaceutics, analytical chemistry, organic chemistry, chemical engineering, or a related discipline.Direct experience in Regulatory CMC.Demonstrated experience driving change initiative projects.Who We Are:Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families, and the communities they care for. Our Vision is clear: A better and healthier every day for every woman.As an equal opportunity employer, we welcome applications from candidates with diverse backgrounds. We are committed to creating an inclusive environment for all our applicants.If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at ****** Salary RangeEmployee Status: RegularRelocation: No relocationVISA Sponsorship: YesTravel Requirements: Organon employees must satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites - 10%Number of Openings: 1Requisition ID: R528136
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Lisboa, Lisboa, Portugal Organon Tempo inteiroJob Title: Associate Principal Scientist, Regulatory Affairs Chemistry ManufacturingOrganon is seeking a highly skilled Associate Principal Scientist to join our Regulatory Affairs Chemistry Manufacturing team. As a key member of our team, you will be responsible for providing regulatory CMC support for Organon Network Projects.Key Responsibilities:Lead the...
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Lisboa, Lisboa, Portugal Organón Tempo inteiroJob Title: Associate Principal Scientist, Regulatory Affairs Chemistry ManufacturingThe position of Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing, is a key role within Organon's Chemistry, Manufacturing & Controls (CMC) team. This individual will provide regulatory CMC support for Organon Network Projects, leading the preparation...
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Lisboa, Portugal Organon Tempo inteiroReporting to the Established Brands Dermatology Portfolio lead in our Company's Regulatory Chemistry, Manufacturing & Controls (CMC), the Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned small molecule or biological products in accordance with global regulations and guidance's, and Company...
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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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Associate Principal Scientist, Regulatory
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Lisboa, Portugal Organon Tempo inteiro**The Position** The Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned small molecule products in accordance with global regulations and guidance's, and Company procedures. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for life-cycle maintenance...
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Lisboa, Lisboa, Portugal Organón Tempo inteiroJob DescriptionThe PositionOrganon Manufacturing & Supply (OMS) is seeking an Associate Director (Associate Principal Scientist), Chemistry, Manufacturing & Controls (CMC), Network Project & Resource Management to 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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Regulatory Affairs Chemistry Manufacturing Associate Director
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Lisboa, Lisboa, Portugal Organón Tempo inteiroJob Title: Associate Principal Scientist, Regulatory Affairs Chemistry ManufacturingJob Summary:The Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing 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...
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Associate Principal Scientist, Regulatory Affairs
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Lisboa, Portugal Organon Tempo inteiro**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...
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Lisboa, Lisboa, Portugal Organon Tempo inteiroJob DescriptionThe RoleWe are seeking an experienced Associate Principal Scientist to join our Regulatory Affairs Chemistry Manufacturing team. As a key member of our team, you will provide regulatory CMC support for Organon Network Projects, leading the preparation and submission of CMC dossiers for assigned projects.ResponsibilitiesManage processes and...
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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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Associate Principal Scientist, Regulatory Affairs
2 meses atrás
Lisboa, Portugal Organon 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...
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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 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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Lisboa, Portugal Biom?Rieux Bv 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 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 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 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...
