Regulatory Affairs Lead
hace 4 días
The Regulatory Affairs Lead for North America at Thermo Fisher Scientific plays a pivotal role in ensuring compliance with local, regional, and ICH regulatory requirements. This dynamic professional provides innovative solutions to support product development from preclinical stages through registration and optimization.
Key Responsibilities:- Provides senior review and advice to prepare regional regulatory submissions, adhering to high-quality standards that meet or exceed client expectations.
- Serves as a subject matter expert, offering regulatory strategy advice and technical expertise to internal and external clients on key projects of moderate to high complexity.
- Evaluates quality performance for managed projects, manages project budgeting/forecasting functions, and identifies out-of-scope activities in contracts.
- Collaborates with business development in pricing and securing new business through presentations and proposal development.
- Mentors junior team members, providing guidance and training.
- Oversees all submission types to Regulatory Authorities and/or EC/local submissions, including North America IRB submissions.
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Regulatory Affairs Strategic Lead
hace 3 semanas
Ciudad de México, Ciudad de México Gilead Sciences Mexico, S. de R.L. de C.V. A tiempo completoAt Gilead Sciences Mexico, S. de R.L. de C.V., we are seeking a seasoned Regulatory Affairs professional to join our team as a Regulatory Affairs Strategic Lead.About the RoleThis is an exciting opportunity for a highly skilled and experienced individual to play a key role in shaping our regulatory strategies and ensuring compliance with applicable...
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Regulatory Affairs Strategist
hace 3 semanas
Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completoIn the role of Regulatory Affairs Strategist at Thermo Fisher Scientific, you will be part of our Regulatory Liaison team, leading on communications with regulatory agencies as part of centralized regulatory submissions including but not limited to the EU CTR process. You will partner with our Regulatory Affairs leads, in providing regulatory affairs...
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Regulatory Affairs Strategist
hace 4 semanas
Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completoIn a pivotal role at Thermo Fisher Scientific, the Sr Regulatory Affairs Specialist will be part of our Regulatory Liaison team, spearheading communications with regulatory agencies as part of centralized regulatory submissions. This includes collaboration with regulatory affairs leads to provide strategic guidance and technical/project leadership on a...
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Regulatory Affairs Professional
hace 3 semanas
Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completoJob SummaryWe are seeking a highly skilled Sr Regulatory Affairs Specialist to join our team at Thermo Fisher Scientific. As a key member of our Regulatory Liaison team, you will play a critical role in 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 Expert
hace 1 mes
Ciudad de México, Ciudad de México Gilead Sciences A tiempo completoAbout Gilead SciencesGilead Sciences is a leading biopharmaceutical company dedicated to creating innovative therapies that improve lives. With over 35 years of experience, we have developed treatments for HIV, viral hepatitis, COVID-19, and cancer.We are committed to delivering exceptional results while maintaining regulatory compliance and ensuring access...
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Regulatory Affairs Senior Manager
hace 4 semanas
Ciudad de México, Ciudad de México Gilead Sciences A tiempo completoGilead Sciences is a leading biopharmaceutical company dedicated to creating life-changing treatments for patients worldwide.We are seeking an experienced Regulatory Affairs Senior Manager to join our team in Mexico City. This role offers a competitive salary of approximately $120,000 per year, depending on experience and qualifications.Job DescriptionThis...
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Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completoJob OverviewWe are seeking a highly skilled Regulatory Affairs Lead to oversee the preparation and submission of regulatory documentation in North America. The successful candidate will provide innovative regulatory solutions, ensuring compliance with current local, regional, and ICH requirements.About Thermo Fisher ScientificThermo Fisher Scientific is a...
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Regulatory Affairs Director
hace 4 semanas
Ciudad de México, Ciudad de México Gilead Sciences Mexico, S. de R.L. de C.V. A tiempo completoJob OverviewWe are seeking a highly experienced and skilled Regulatory Affairs Director to join our team in Mexico City. This is an exciting opportunity for a regulatory professional to lead the development and execution of regulatory strategies, ensuring compliance with applicable regulations.Job DescriptionThe successful candidate will have extensive...
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Regulatory Affairs Manager
hace 3 semanas
Ciudad de México, Ciudad de México Gilead Sciences A tiempo completoAbout the OpportunityWe are seeking a highly skilled and experienced Regulatory Affairs Manager to join our team in Mexico City. As a key member of our Regulatory Affairs department, you will be responsible for developing and executing regulatory strategies to ensure compliance with applicable regulations and maximize regulatory success.Job Summary
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Clinical Trials Regulatory Affairs Expert
hace 6 días
Ciudad de México, Ciudad de México ICON Plc A tiempo completoSenior Regulatory Affairs SpecialistWe're seeking a highly skilled Clinical Trials Regulatory Affairs Expert to join our team at ICON Plc. This is an exciting opportunity to leverage your expertise in regulatory affairs and contribute to the success of our clinical trials.About the Role:Lead the preparation, submission, and maintenance of regulatory...
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Regulatory Affairs Specialist
hace 4 semanas
Ciudad de México, Ciudad de México ProductLife Group A tiempo completoWe are seeking a skilled Regulatory Affairs Officer to join our team at ProductLife Group. The successful candidate will be responsible for ensuring the delivery of regulatory activities on a global level.Job Description:The Regulatory Affairs Officer will contribute to the production of client administrative documents for regulatory submissions, compile...
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Global Regulatory Affairs Specialist
hace 4 semanas
Ciudad de México, Ciudad de México Novo Nordisk AS A tiempo completoAbout Novo Nordisk A/SNovo Nordisk A/S is a leading healthcare company that aims to drive change and improve patient lives. Our Global Business Service Centre in Mexico City is a vibrant hub with a dynamic and collaborative atmosphere.Salary Range: $80,000 - $110,000 per yearJob DescriptionAs a Regulatory Affairs Coordinator at Novo Nordisk A/S, you will...
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Regulatory Affairs Specialist in Canada
hace 4 semanas
Ciudad de México, Ciudad de México ProductLife Group A tiempo completoJob TitleRegulatory Affairs Specialist in CanadaAbout UsProductLife Group is a leading provider of regulatory services for the pharmaceutical industry.Job DescriptionWe are seeking an experienced Regulatory Affairs Specialist to join our team in Mexico or Canada. As a Regulatory Affairs Specialist, you will be responsible for managing post-approval...
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Regulatory Affairs Director
hace 4 semanas
Ciudad de México, Ciudad de México Gilead Sciences Mexico, S. de R.L. de C.V. A tiempo completoAt Gilead Sciences Mexico, S. de R.L. de C.V., we are seeking a highly skilled Regulatory Affairs Director to join our team in Mexico City.The estimated annual salary for this position is $450,000-$600,000, depending on experience and qualifications.About the RoleThis exciting opportunity involves defining, developing, and executing regulatory strategies to...
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Regulatory Affairs Specialist
hace 3 semanas
Ciudad de México, Ciudad de México 3M A tiempo completoJob DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Mexico City.OverviewAs a Regulatory Affairs Specialist, you will play a key role in coordinating regulatory strategy for the Consumer Health Group division. You will provide support and expertise as part of the Regulatory organization, using your knowledge of...
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Regulatory Affairs Director
hace 4 semanas
Ciudad de México, Ciudad de México Gilead Sciences A tiempo completoAbout Gilead Sciences">Gilead Sciences is a biopharmaceutical company committed to creating a healthier world for all people.With over 35 years of experience, we've tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer, working relentlessly to develop therapies that improve lives and ensure access across the globe.We continue to fight against...
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Regulatory Affairs Expert with Global Reach
hace 4 semanas
Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completoAt Thermo Fisher Scientific, we are seeking a highly skilled Sr Regulatory Affairs Specialist to join our team.The ideal candidate will have a strong background in regulatory affairs and excellent communication skills. In this role, you will be responsible for providing regulatory advice and guidance to internal stakeholders, as well as developing and...
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Regulatory Affairs Specialist for Life Cycle Management
hace 4 semanas
Ciudad de México, Ciudad de México ProductLife Group A tiempo completoProductLife Group - Regulatory Affairs OfficerWe are seeking a highly skilled Regulatory Affairs Officer to manage post-MAA activities (Life Cycle Management) for the Canadian market.This role is ideal for an individual with a strong background in regulatory affairs and experience in managing post-approval activities. As a Regulatory Affairs Officer, you...
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Regulatory Affairs Expert
hace 3 semanas
Santiago de Querétaro, Querétaro de Arteaga, México Kerry A tiempo completoOverviewKerry, a leading player in the food industry, is seeking a highly skilled Regulatory Affairs Expert to join its team. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with relevant regulations and laws.
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Regulatory Affairs Professional
hace 3 semanas
Ciudad de México, Ciudad de México Novo Nordisk AS A tiempo completoNovo Nordisk A/S is seeking a skilled Regulatory Affairs Coordinator to join its GBS Mexico City team.About the RoleThe successful candidate will be responsible for supporting the compilation, submission, and approval of Country Specific Submissions files for designated countries. They will also assist affiliates in reviewing labelling materials and...