Regulatory Affairs Specialist
hace 1 día
ProductLife Group is seeking a highly skilled Regulatory Affairs Officer to manage post-MAA activities for the Canadian market.
Responsibilities- Manage post-approval activities (Life Cycle Management) for the Canadian market, ensuring compliance with Health Canada guidelines.
- Initiate change controls, including regulatory assessments and coordinate subsequent regulatory steps until closure.
- Compile regulatory dossiers in accordance with national requirements and document regulatory submissions and approvals.
- Provide review of packaging texts, format reviews of Summary of Product Characteristics, Patient Information Leaflets, and labeling, ensuring QRD compliance.
- Contribute to data entry in PLG tools, enabling measurements of KPIs and metrics for regulatory services.
- Bachelor's degree or more in a Life Sciences related field, with a Pharmacy degree being a plus.
- At least 2 years of experience in Regulatory Affairs in the Pharmaceutical Industry or via a Service Provider.
- Experience in regulatory lifecycle maintenance activities for drug products in Canada, including renewals, change controls, and PI updates.
- Knowledge of Canadian regulations for pharmaceuticals, medical devices, and combination products.
- Fluent English is mandatory, with French being a great plus.
- Excellent organizational, interpersonal, and communication skills, with the ability to work well within a team and autonomously.
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Regulatory Affairs Specialist
hace 4 días
Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completoRegulatory Affairs SpecialistThermo Fisher Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our Regulatory Liaison team. As a key member of our team, you will be responsible for leading communications with regulatory agencies and providing regulatory affairs strategy and technical/project leadership on a regional/global level.Key...
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Regulatory Affairs Specialist
hace 1 semana
Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completoJob SummaryThermo Fisher Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our Regulatory Liaison team. As a key member of our team, you will be responsible for leading communications with regulatory agencies and providing regulatory affairs strategy and technical/project leadership on a regional/global level.Key...
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Regulatory Affairs Specialist
hace 1 día
Ciudad de México, Ciudad de México Kenvue A tiempo completoKenvue is a leading healthcare company that is part of the Johnson & Johnson Family of Companies. We are currently seeking a highly skilled Regulatory Affairs Specialist to join our team in Mexico City. The successful candidate will be responsible for ensuring compliance with regulatory agency regulations and interpretations, preparing responses to...
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Regulatory Affairs Specialist
hace 2 semanas
Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo**Job Summary**Thermo Fisher Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Liaison team, you will be responsible for leading on communications with regulatory agencies as part of centralized regulatory submissions.**Key Responsibilities**Provide regulatory advice and carry out...
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Regulatory Affairs Specialist
hace 1 día
Ciudad de México, Ciudad de México Kenvue A tiempo completoJob Title: Regulatory Affairs SpecialistKenvue is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory agency regulations and interpretations.Key Responsibilities:Develop and maintain regulatory strategies and submissions...
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Regulatory Affairs Specialist LATAM
hace 2 semanas
Ciudad de México, Ciudad de México Medtronic A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Medtronic. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for medical devices in the LATAM region.Key ResponsibilitiesCoordinate and prepare document packages for regulatory submissions,...
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Regulatory Affairs Expert
hace 1 día
Ciudad de México, Ciudad de México 520 ICR Mexico - MEX A tiempo completoSenior Regulatory Affairs SpecialistAbout the RoleWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at 520 ICR Mexico - MEX. As a key member of our regulatory affairs team, you will play a critical role in ensuring compliance with regulatory requirements and facilitating the successful execution of clinical trials.Key...
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Regulatory Affairs Specialist
hace 1 día
Ciudad de México, Ciudad de México Fenixfarma Mexico City, Mexico A tiempo completo{"h1": "Regulatory Affairs Coordinator", "p": "Fenixfarma Mexico City, Mexico is seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with local health regulations and leading a team of regulatory specialists to achieve product...
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Regulatory Affairs Specialist
hace 2 días
Ciudad de México, Ciudad de México ProductLife Group A tiempo completoRegulatory Affairs Officer Job DescriptionWe are seeking a highly skilled Regulatory Affairs Officer to join our team at ProductLife Group.Key Responsibilities:Contribute to the production of client administrative documents for regulatory submissionsCompile regulatory dossiers in accordance with national requirementsManage systems and administer regulatory...
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Regulatory Affairs Specialist
hace 1 día
Ciudad de México, Ciudad de México Solventum A tiempo completo{"title": "Regulatory Affairs Coordinator", "description": "Job Overview:Solventum is seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a key member of our regulatory affairs team, you will play a critical role in ensuring compliance with regulatory requirements for our medical devices.Key Responsibilities:Review and support...
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Regulatory Affairs Specialist
hace 2 semanas
Ciudad de México, Ciudad de México Philips Iberica SAU A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Philips Iberica SAU. As a key member of our Regulatory Affairs team, you will be responsible for guiding and supporting our businesses, markets, and supporting functions in the Mexico market to ensure compliance with regulatory requirements.Key...
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Regulatory Affairs Specialist
hace 2 semanas
Ciudad de México, Ciudad de México Fenixfarma Mexico City, Mexico A tiempo completoJob Title: Regulatory Affairs CoordinatorCompany: Fenixfarma Mexico City, MexicoJob Summary:We are seeking a highly skilled Regulatory Affairs Coordinator to join our team in Mexico City. The successful candidate will be responsible for ensuring compliance with local health regulations and leading a team of regulatory specialists to achieve product...
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Regulatory Affairs Specialist
hace 1 día
Ciudad de México, Ciudad de México Ortho Clinical Diagnostics A tiempo completoThe OpportunityAt Ortho Clinical Diagnostics, we are a world-leading in vitro diagnostics company with a strong presence in over 130 countries. Our mission is to transform the power of diagnostics into a healthier future for all. We are seeking a highly skilled Regulatory Affairs Associate to join our team.Key ResponsibilitiesPrepare and submit regulatory...
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Senior Regulatory Affairs Specialist
hace 1 semana
Ciudad de México, Ciudad de México Icon plc A tiempo completoJob SummaryWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at ICON plc. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with regulatory requirements and facilitating the successful execution of clinical trials.Key ResponsibilitiesRegulatory Document Preparation...
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Regulatory Affairs Specialist
hace 1 semana
Ciudad de México, Ciudad de México ICON Plc A tiempo completoJob SummaryICON Plc is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will play a pivotal role in ensuring regulatory compliance and facilitating the successful execution of clinical trials.Key ResponsibilitiesRegulatory ComplianceLead the preparation, submission, and...
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Regulatory Affairs Specialist
hace 1 día
Ciudad de México, Ciudad de México Csl Behring A tiempo completoJob SummaryCsl Behring is seeking a highly skilled Regulatory Affairs Analyst to join our team. As a key member of our Global Regulatory Affairs team, you will play a critical role in ensuring the compliance of our products in the assigned region.Key ResponsibilitiesSupport the Regional Regulatory group with review of documentation for NDAs, renewals,...
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Regulatory Affairs Specialist
hace 1 día
Ciudad de México, Ciudad de México Reser's Fine Foods, Inc. A tiempo completo{"h3": "Regulatory Affairs Specialist Role Overview"} The Regulatory Affairs Specialist is a key member of our team, responsible for ensuring that all Reser's brand labels meet the highest standards of legal accuracy, regulatory compliance, and overall correctness. Key Responsibilities Collaborate with internal stakeholders to develop and approve product...
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Regulatory Affairs Specialist
hace 2 semanas
Ciudad de México, Ciudad de México QuidelOrtho A tiempo completoAbout the OpportunityQuidelOrtho, a world-leading in vitro diagnostics company, is seeking a highly skilled Regulatory Affairs Associate to join our team. With a strong presence in over 130 countries, we provide fast, accurate, and consistent testing solutions where and when they are needed most.Our company culture prioritizes employee happiness,...
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Regulatory Affairs Specialist
hace 1 semana
Ciudad de México, Ciudad de México Kenvue A tiempo completoAbout KenvueKenvue, part of the Johnson & Johnson Family of Companies, is a leading healthcare company that believes in the extraordinary power of everyday care. With a rich heritage and propelled forward by science, our iconic brands are trusted by millions of consumers who use our products to improve their daily lives.Job SummaryWe are seeking a highly...
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Regulatory Affairs Expert
hace 1 día
Ciudad de México, Ciudad de México ICON Plc A tiempo completoAbout the RoleWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at ICON Plc. As a key member of our regulatory affairs team, you will play a critical role in ensuring compliance with regulatory requirements and facilitating the successful execution of clinical trials.Key ResponsibilitiesPrepare, submit, and maintain...