Regulatory Submission Specialist

In this role as a Regulatory Affairs Specialist, you will be part of our Regulatory Liaison team, leading on communications with regulatory agencies as part of centralized regulatory submissions. You will partner with our Regulatory Affairs leads, in providing regulatory affairs strategy and technical/project leadership on a regional/global level.Key...

Job OverviewMEX Labcorp Clinical Development, S. de R.L. de C.V. is seeking a highly motivated Regulatory Compliance Specialist to join our team. As a key member of our clinical development team, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the assigned countries.Key Responsibilities:Maintain awareness of...

Job Description:We are looking for a skilled Regulatory Document Specialist to develop new projects that include managing and preparing regulatory applications in eCTD format. Key responsibilities include ensuring timely and accurate submissions, performing quality control, and maintaining knowledge of FDA, HC, and ICH requirements.Key...

Job SummaryWe are seeking a highly skilled Regulatory Publishing Specialist to join our team at Thermo Fisher Scientific. In this role, you will be responsible for coordinating and managing client electronic submission deliverables to support regulatory compliance.Key ResponsibilitiesCoordinate and manage client electronic submission deliverables to ensure...

The OpportunityOrtho Clinical Diagnostics is expanding its team with a Regulatory Affairs Associate who will play a key role in the preparation and submission of regulatory dossiers.As part of our in vitro diagnostics team, you will be responsible for coordinating technical and legal documentation, preparing new and renewal submission dossiers, and...

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, MEX Labcorp Clinical Development, S. de R.L. de C.V. provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than...

We are seeking a skilled Regulatory Publisher to join our team at ProductLife Group. As a key member of our regulatory team, you will be responsible for managing and preparing regulatory applications in eCTD format for submission to the applicable regulatory authority.Key Responsibilities:Manage and prepare IND, NDA, BLA, and DMF regulatory applications in...

In 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...

The 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...

Position 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 Specialist with Expertise in Clinical TrialsAt ICON Plc, we're seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for leading the preparation, submission, and maintenance of regulatory documents for clinical trials. Your expertise in clinical...

Position 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...

We are looking for a skilled Regulatory Publisher to join our team at ProductLife Group. This role involves developing new projects and managing regulatory applications in eCTD format for submission to the FDA and HC.Key ResponsibilitiesManage and prepare IND, NDA, BLA, and DMF regulatory applications in eCTD format for submission.Perform quality control...

Senior Regulatory Affairs Specialist with a strong track record in Clinical TrialsAt ICON Plc, we're seeking an experienced Regulatory Affairs Specialist to join our team. This role will be responsible for leading the preparation, submission, and maintenance of regulatory documents for clinical trials.Provide expertise and guidance on regulatory requirements...

Job OverviewMEX Labcorp Clinical Development, S. de R.L. de C.V. is seeking a highly skilled Regulatory Specialist to play a key role in the success of our clinical trials. As a Regulatory Specialist, you will be responsible for ensuring compliance with regulatory requirements and guidelines, coordinating with investigative sites, and maintaining awareness...

Regulatory 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...

Job Title: Senior Regulatory Affairs Specialist with Experience in Clinical TrialsJob Summary:We are seeking a Senior Regulatory Affairs Specialist to join our team at 520 ICR Mexico - MEX. As a Senior Regulatory Affairs Specialist, you will play a key role in ensuring regulatory compliance and facilitating the successful execution of clinical trials.Key...

Regulatory 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...

Job Overview:Lenovo is seeking a skilled Customer Regulatory Compliance Support Specialist to join its Corporate Compliance team. This role will be responsible for providing regulatory compliance-based support for Lenovo's customers and sales. The successful candidate will work closely with business unit teams to ensure compliance projects are completed and...

Position OverviewWe are seeking a highly skilled Regulatory Affairs Coordinator to join our team in GBS Mexico City. As a key member of our team, you will be responsible for supporting the compilation, submission, and approval of Country Specific Submissions files for the responsible countries.Key ResponsibilitiesProvide support on the compilation,...