Regulatory Affairs Professional
hace 1 día
We 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 Responsibilities- Regulatory Advice and Project Management: Provides regulatory advice and carries out projects in the provision of regulatory affairs services, including assessment of regulatory documents, preparation and assembly of global regulatory submissions, and QC review of the final submission package.
- Liaison with Stakeholders: Acts as liaison with internal stakeholders in the provision of these services, ensuring seamless communication and collaboration.
- Interface with Project Teams: Interfaces with PPD project teams and Health Authorities regarding regulatory strategy/submission activities, developing and maintaining cooperative working relationships.
- Advisory Role: Advises and directs project team members on their responsibilities relative to regulatory strategy/submission activities, acts as a key liaison between Regulatory Affairs Department and project team for assigned projects.
To be successful in this role, you will need:
- Education: Bachelor's Degree; degree in Pharmacy or Life Science is an advantage.
- Experience: Previous regulatory experience, or combination of higher education/less experience or substitution of equivalent relevant work experience will be considered.
- Skills and Abilities: Some regulatory affairs experience is preferable but not mandatory, excellent English language communication skills, both verbal and in writing, computer skills (Microsoft office) and experience in applications used in clinical trials (eTMF, CTMS) would be an advantage.
Thermo Fisher Scientific is a world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. We value diversity, equity, and inclusion, and we strive to create a workplace that reflects these values.
-
Regulatory Affairs Professional
hace 1 mes
Ciudad de México, Ciudad de México Icon Plc A tiempo completoThe Regulatory Affairs Specialist will contribute to the preparation, compilation, and submission of regulatory documents, including CT/IND, MAA, and NOA. Key Responsibilities:- Regulatory Document Preparation: Prepare and submit regulatory documents in a timely and accurate manner.- Collaboration with Teams: Work with the Regulatory Submissions team and...
-
Regulatory Affairs Professional
hace 1 día
Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completoJob OverviewWe are seeking a highly skilled Regulatory Affairs Professional to join our team at Worldwide Clinical Trials. In this role, you will be responsible for planning, initiating, and tracking documents required for regulatory submissions, as well as coordinating with local investigators and key site personnel.About the RoleThis is a full-time...
-
Regulatory Affairs Manager
hace 3 semanas
Ciudad de México, Ciudad de México Solventum A tiempo completoJob OverviewSolventum is seeking a highly skilled Regulatory Affairs Specialist to join our team in Mexico. As a Regulatory Affairs Specialist, you will be responsible for providing general regulatory support for medical products sold in Mexico, including managing medical product licenses with COFEPRIS, reviewing and approving product labeling and...
-
Regulatory Affairs Strategic Lead
hace 7 días
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...
-
Regulatory Affairs Specialist
hace 4 semanas
Ciudad de México, Ciudad de México Qiagen A tiempo completoRegulatory Affairs Manager RoleWe are seeking an experienced Regulatory Affairs Manager to lead and undertake regulatory responsibility for Mexico and Central Americas to ensure our IVD products comply with regional regulations and laws.This role involves developing and implementing regulatory strategies to facilitate product approvals, registrations, and...
-
Regulatory Affairs Strategist
hace 1 día
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...
-
Regulatory Affairs Strategist
hace 2 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...
-
Regulatory Affairs Specialist
hace 3 semanas
Ciudad de México, Ciudad de México Novo Nordisk AS A tiempo completoPosition for Novo Nordisk GBS MexicoPursue a challenging career in regulatory affairs with Novo Nordisk's Global Business Service Centre in Mexico City.We are seeking a highly skilled Regulatory Affairs Coordinator to support the compilation, submission, and approval of Country Specific Submissions files for responsible countries.Key ResponsibilitiesSupport...
-
Regulatory Affairs Manager
hace 3 semanas
Ciudad de México, Ciudad de México Gilead Sciences Mexico, S. de R.L. de C.V. A tiempo completoDescriptionAt Gilead Sciences Mexico, S. de R.L. de C.V., we are seeking a talented Regulatory Affairs professional to join our Regulatory Affairs team. This is a unique opportunity to work on advancing therapeutics while ensuring regulatory compliance.This role involves close collaboration with various stakeholders to define, develop, and execute regulatory...
-
Regulatory Affairs Director for Mexico
hace 3 semanas
Ciudad de México, Ciudad de México Gilead Sciences A tiempo completoJob OverviewGilead Sciences is seeking an experienced Regulatory Affairs professional to join our team in Mexico City. This exciting opportunity will allow you to leverage your expertise in regulatory strategy, compliance, and stakeholder management to drive success in the Mexican market.
-
Regulatory Affairs Specialist
hace 1 mes
Ciudad de México, Ciudad de México ProductLife Group A tiempo completoRegulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ProductLife Group. As a Regulatory Affairs Specialist, you will be responsible for managing post-approval activities for the Canadian market, including life cycle management, change controls, and regulatory submissions.Key Responsibilities:Manage...
-
Regulatory Affairs Manager
hace 1 mes
Ciudad de México, Ciudad de México Pharmanovia A tiempo completoAbout the RoleAs a Regulatory Affairs Manager, you will lead the establishment of Regulatory Affairs management in the LATAM region. You will be responsible for all aspects of the LATAM Regulatory Strategy, supporting the growth of the pipeline in LATAM.Key ResponsibilitiesLead Pharmanovia's Regional operations strategically aligned to growth plans in...
-
Regulatory Affairs Professional
hace 1 día
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...
-
Regulatory Affairs Specialist
hace 3 semanas
Ciudad de México, Ciudad de México Solventum A tiempo completoJob Description:Regulatory Affairs Specialist, Mexico (Solventum)Solventum is a company committed to innovation and excellence in the healthcare sector. We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Mexico.Key Responsibilities:Provide regulatory support for medical products sold in Mexico, including managing licenses with...
-
Regulatory Affairs Expert
hace 2 semanas
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...
-
Regulatory Affairs Senior Manager
hace 2 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...
-
Regulatory Affairs Specialist
hace 2 semanas
Ciudad de México, Ciudad de México Novo Nordisk AS A tiempo completoPosition OverviewWe are seeking a Regulatory Affairs Coordinator to join our team in GBS Mexico City. As a key member of our Global Business Service team, you will be responsible for supporting the compilation, submission, and approval of Country Specific Submissions files.About the RoleAs a Regulatory Affairs Coordinator at Novo Nordisk A/S, your main...
-
Regulatory Affairs Director
hace 2 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...
-
Regulatory Affairs Specialist
hace 1 mes
Ciudad de México, Ciudad de México Ortho Clinical Diagnostics A tiempo completoThe OpportunityAt Ortho Clinical Diagnostics, we are committed to delivering innovative solutions that transform the power of diagnostics into a healthier future for all. We are seeking a highly skilled Regulatory Affairs Associate to join our team and contribute to our mission.Key ResponsibilitiesPrepare and submit regulatory documents, including technical...
-
Regulatory Affairs Manager
hace 1 mes
Ciudad de México, Ciudad de México Gilead Sciences, Inc. A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Gilead Sciences, Inc. in Mexico City. As a key member of our Regulatory Affairs team, you will be responsible for developing and executing regulatory strategies to ensure compliance with applicable regulations and maximize regulatory success.This is an exciting...