Country Approval Specialist

2 meses atrás


São Paulo SP, Brasil Thermo Fisher Scientific Tempo inteiro

**Work Schedule**

Other

**Environmental Conditions**

Office
- Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
- Provides project specific local SIA services and coordination of these projects.
- May have contact with investigators for submission related activities.
- Key-contact at country level for either Ethical or Regulatory submission-related activities.
- Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
- Achieves PPD’s target cycle times for site.
- May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
- May develop country specific Patient Information Sheet/Informed Consent form documents.
- Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
- Enters and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
- Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
- Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided



  • São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    Job Summary:Thermo Fisher Scientific is seeking a highly skilled Country Approval Specialist to join our team. As a key member of our global compliance team, you will play a critical role in ensuring the accuracy and timeliness of country submissions.Key Responsibilities:Prepare, review, and coordinate local regulatory submissions in alignment with our...

  • Country Approval Specialist

    3 semanas atrás


    São Paulo, Brasil PPD Latin America Tempo inteiro

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...


  • São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy. Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal...


  • Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients. - Provides project specific local SIA services and coordination of these projects. - May have contact with investigators for submission related activities. - Key-contact at country level for either Ethical or Regulatory submission-related activities. - Coordinates,...

  • Ctry Approval Spec

    3 meses atrás


    São Paulo, SP, Brasil Thermo Fisher Scientific Tempo inteiro

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Position Overview**: As a Country Approval Specialist, you will participate in the management and preparation, review and coordination of Country Submissions in line with global submission strategy in order to activate investigative sites. You have a strong attention to detail,...


  • São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    Job SummaryWe are seeking a highly skilled Country Approval Specialist to join our team at Thermo Fisher Scientific. As a key member of our regulatory affairs team, you will be responsible for preparing, reviewing, and coordinating local regulatory submissions in alignment with our global submission strategy.Key ResponsibilitiesLocal Regulatory Strategy:...

  • Ctry Approval Spec

    3 meses atrás


    São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    Position Overview: As a Country Approval Specialist, you will participate in the management and preparation, review and coordination of Country Submissions in line with global submission strategy in order to activate investigative sites. You have a strong attention to detail, taking ownership of the accuracy of these documents while holding...


  • São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    Job Summary:We are seeking a highly skilled Country Regulatory Specialist to join our team at Thermo Fisher Scientific. As a key member of our regulatory affairs team, you will play a critical role in the management and preparation of local regulatory submissions, ensuring compliance with global submission strategies and regulatory guidelines.Key...


  • São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    Position Overview:As a Country Regulatory Specialist at Thermo Fisher Scientific, you will play a pivotal role in the management and preparation, review, and coordination of Country Submissions in line with our global submission strategy to activate investigative sites. You will possess a strong attention to detail, taking ownership of the accuracy of these...


  • São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    Country Regulatory Compliance SpecialistMain Responsibilities:Provides regulatory strategy advice to internal clients.Coordinates project-specific local SIA services.Ensures alignment of submission process for sites and study with critical path for site activation.Maintains knowledge of PPD SOPs, Client SOPs/directives, and current regulatory guidelines.Key...


  • São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    **Job Summary**We are seeking a highly skilled Country Regulatory Specialist to join our team at Thermo Fisher Scientific. As a key member of our global submission team, you will play a critical role in the management and preparation of country submissions in line with our global submission strategy.**Key Responsibilities**:Provides local regulatory strategy...


  • São Paulo, São Paulo, Brasil Pfizer Tempo inteiro

    Job Title: Country Brand Lead Oncology SpecialistAbout the Role:We are seeking a highly skilled Country Brand Lead Oncology Specialist to join our team at Pfizer. As a key member of our marketing team, you will be responsible for developing and implementing marketing strategies to promote our oncology products in the country.Key Responsibilities: Partner...


  • São Paulo, São Paulo, Brasil PPD Latin America Tempo inteiro

    Role Summary:As a Country Regulatory Specialist at PPD Latin America, you will play a critical role in the management and preparation of local regulatory submissions in line with our global submission strategy. Your expertise will ensure compliance with regional and national country regulatory guidelines and EC regulations.Key Responsibilities:Prepare,...


  • São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    Job Summary:We are seeking a highly skilled Country Regulatory Specialist to join our team at Thermo Fisher Scientific. As a key member of our regulatory affairs team, you will play a critical role in the management and preparation of local regulatory submissions, ensuring compliance with global submission strategies and regulatory guidelines.Key...


  • São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    Job Summary:We are seeking a highly skilled Country Regulatory Specialist to join our team at Thermo Fisher Scientific. As a key member of our regulatory affairs team, you will play a critical role in the management and preparation of local regulatory submissions, ensuring compliance with global submission strategies and regulatory guidelines.Key...


  • São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    Job SummaryWe are seeking a highly skilled Country Approval Specialist to join our team at Thermo Fisher Scientific. As a key member of our regulatory affairs team, you will play a critical role in ensuring the successful submission and approval of our products in various countries.Key ResponsibilitiesRegulatory Submission Coordination: Prepare, review, and...


  • São Paulo, Brasil Catho Online Ltda. - BR - Specialist Tempo inteiro

    Marketing Specialist - VIE ContractLocation: Brazil, São Paulo Target start date: 01/03/2025 iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.PLEASE NOTE: Since this program is primarily an international development program, candidates cannot apply to a VIE...


  • São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    Job SummaryAs a Country Regulatory Compliance Specialist at Thermo Fisher Scientific, you will provide local regulatory strategy advice to internal clients and coordinate project-specific services. Key responsibilities include providing project-specific local SIA services, coordinating with internal departments, and ensuring alignment of submission...


  • São Paulo, São Paulo, Brasil Ppd Latin America Tempo inteiro

    Job Summary:As a Country Regulatory Compliance Specialist at Ppd Latin America, you will play a crucial role in the management and preparation of Country Submissions in line with our global submission strategy.Key Responsibilities:Prepares, reviews, and coordinates local regulatory submissions (MoH, EC, additional special national local applications if...

  • Country Director

    Há 1 mês


    São Paulo, SP, Brasil Safeguard Global Recruiting Tempo inteiro

    Advancing the welfare of animals in more than 50 countries, Humane Society International works around the globe to promote the human-animal bond, rescue and protect dogs and cats, improve farm animal welfare, protect wildlife, promote animal-free testing and research, respond to disasters and confront cruelty to animals in all of its forms. Country...