Senior Regulatory Specialist

1 dia atrás

Brazil, BR Fortrea Tempo inteiro

Job Overview:

Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/IRB/Third body/Regulatory Authority and any other local applications are made within the timelines agreed with project management and Site Readiness team and that documentation meets the specifications required by applicable regulations and sponsor. Proactively interacts with EC/IRB/Third body/Regulatory Authorities to provide guidance regarding requirements. Maintain awareness of current regulatory standards related to submissions. Serve as local expert in project start-up activities for a particular country or region. Act as a ‘knowledge resource’ to mentor and train new hires and less-experienced department colleagues if suitable.


Summary of Responsibilities:



  • Maintain awareness of regulatory legislation, guidance, and practice in the assigned countries.
  • Coordinate, collect and organize data and information required by EC/IRB/Third body/Regulatory Authority including but not limited to the preparation of study documentation such as the country application form and cover letter for sponsor review as applicable.
  • Compile and prepare routine submission filed to IRB/IEC/Third body/Regulatory Authorities (e.g., INDs/CTAs) and liaise with them as applicable regarding submission/approval.
  • Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable).
  • Perform a review of final submission documents as applicable.
  • Ensure that all assigned start-up and maintenance activities are on track, in accordance with client expectations and budget and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs and quality standards
  • Prevent and escalate study issues appropriately and in a timely fashion.
  • Perform other duties as assigned by management depending upon country and situational requirements with proper supervision [if applicable].
  • In Country specific tasks (Global):
  • Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.
  • Collect and track all the necessary documents required and perform a quality review, formatting, and compilation of the final documents for effective and compliant site activation and maintenance without supervision.
  • Ensure high quality documents are filed and systems are updated on an ongoing and timely basis, making Fortrea ready for an audit at any time.
  • Participate in team and project meetings as applicable.
  • When needed, assist in the strategy definition for Site Activation and provide accurate projections and timelines to study teams.
  • Review and customize country and site-specific patient informed consent forms for compliance with local requirements and protocol. Proactively resolve informed consent issues and other potential difficulties with study sites.
  • May support the negotiation of site contracts and budgets with sites, if applicable and track progress of contract and budget milestones/developments, intervening and escalating as appropriate.
  • Proactively identifying and escalating to Submission Leads any risk to meeting deliverables.
  • Notify the Submissions Lead of hours identified as Out-of-Scope or overburn.
  • Clinical Trials Information System (CTIS) tasks (specific centralized role for EU):
  • Assist in the upload of submission documentation to, interacting with and monitoring of all notifications and alerts in CTIS to ensure all milestones and events for the trial are met within the timelines mandated.
  • Performs all other duties as needed or assigned.


Qualifications (Minimum Required):

  • University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  • In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations will be considered.


Experience (Minimum Required):

  • Minimum of 3 years of experience in clinical development or start-up/ regulatory process.
  • Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites.
  • Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them.


Physical Demands/Work Environment:

  • General Office Environment.

  • Senior Manager

    1 dia atrás

    Brazil, BR RBW Consulting Tempo inteiro

    RBW Consulting are partnered with a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to...

  • Manager - Accounting Advisory & Financial Reporting (Capital Markets)

    1 dia atrás

    Brazil, BR 10x Advisory Tempo inteiro

    About the RoleWe are seeking a Manager in Accounting Advisory & Financial Reporting to join our growing team. This role is ideal for an experienced accounting professional with expertise in IFRS, US GAAP, and technical accounting matters, particularly in advising businesses through reporting and compliance challenges.The ideal candidate will have experience...

  • Medical Information Nurse

    1 dia atrás

    Brazil, BR Safeguard Global Tempo inteiro

    The Multilingual Medical Information Specialist (MIS) position is part of the ProPharma Medical Information Contact Center and follows all corresponding regulations, industry standards, and client/internal policies regarding medical information and the collection and documentation of adverse events, special situation events, and product complaints.Essential...

  • Senior Full Stack Engineer

    1 dia atrás

    Brazil, BR Smarter Contact Tempo inteiro

    About us:Smarter Contact is the #1 messaging platform for real estate professionals in the U.S. Our SaaS product powers millions of conversations to close more deals through smart SMS, voice, and automation.We’re a fast-growing SaaS with serious traction — and now we’re hiring an experienced Full Stack Engineer to build the internal systems, dev tools,...

  • Senior Regulatory Affairs Specialist

    2 semanas atrás

    Buenos Aires, Espírito Santo, Brazil beBeeCompliance Tempo inteiro R$80.000 - R$120.000

    Senior Regulatory Affairs SpecialistThis senior level position is responsible for overseeing the implementation of regulatory compliance initiatives across various regions. The ideal candidate will have a strong background in regulatory affairs, with experience in developing and implementing strategies to ensure continued compliance.Key...

  • Senior Regulatory Specialist

    Há 12 horas

    Brazil Fortrea Tempo inteiro

    Job Overview: Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/IRB/Third body/Regulatory Authority and any other local applications are made within the timelines agreed with project management and Site...

  • Senior Regulatory Specialist

    Há 6 horas

    Brazil Fortrea Tempo inteiro

    Job Overview:Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/IRB/Third body/Regulatory Authority and any other local applications are made within the timelines agreed with project management and Site...

  • Senior Finance Regulatory Professional

    Há 7 dias

    Buenos Aires, Espírito Santo, Brazil beBeeRegulatory Tempo inteiro US$100.000 - US$150.000

    Financial Regulatory SpecialistAs a Financial Regulatory Specialist, you will be responsible for overseeing the financial activities of two legal entities. This includes ensuring the accuracy and completeness of their financial statements, regulatory reporting, and management reports.Key Responsibilities:Conduct capital analysis, assist in budgeting, and run...

  • Senior Regulatory Affairs Specialist

    Há 7 dias

    Buenos Aires, Espírito Santo, Brazil beBeeRegulatoryAffairs Tempo inteiro R$80.000 - R$130.000

    Job SummaryThis senior regulatory affairs professional will lead the team in supervising professional employees and implementing regulation changes to ensure continued compliance. They will maintain relationships with government agencies and businesses, develop strategies for compliance and risk reduction, and provide direct supervision, guidance, and...

  • Senior Regulatory Specialist

    Há 12 horas

    Federative Republic Of Brazil Fortrea Tempo inteiro

    Job Overview:Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/IRB/Third body/Regulatory Authority and any other local applications are made within the timelines agreed with project management and Site...

  • Senior Regulatory and Accounting Specialist

    1 semana atrás

    Buenos Aires, Espírito Santo, Brazil beBeeAccounting Tempo inteiro US$90.000 - US$120.000

    We are seeking a seasoned Regulatory and Accounting Leader to join our team. This role is responsible for overseeing the financial health of our organization, ensuring compliance with regulatory requirements, and providing strategic guidance to management.Job Description:The successful candidate will have experience in finance, accounting, and regulatory...

  • Regulatory Compliance Specialist

    1 semana atrás

    Buenos Aires, Espírito Santo, Brazil beBeeCompliance Tempo inteiro US$40.000 - US$60.000

    About this roleThis exciting position involves ensuring that our clients maintain regulatory compliance and manage risks effectively. You will be responsible for developing and implementing policies and procedures to facilitate compliance with legal and regulatory requirements.You will work as a reliable, contributing member of a team. In our fast-paced...

  • Senior Business Development Specialist

    Há 5 dias

    Manaus, Pernambuco, Brazil beBeeDevelopment Tempo inteiro R$60.000 - R$90.000

    Job TitleSought after for the position of Senior Business Development Specialist, you will be responsible for generating revenue and expanding our market share through strategic partnerships and business relationships.About the RoleThis is an exciting opportunity to join a dynamic team as a Senior Business Development Specialist. Your primary focus will be...

  • Senior Financial Specialist

    Há 7 dias

    Buenos Aires, Espírito Santo, Brazil beBeeFinancial Tempo inteiro US$59.000 - US$74.000

    Job Title: Senior Financial SpecialistAbout the RoleWe are seeking an experienced financial professional to join our team as a Senior Financial Specialist. The ideal candidate will have a strong background in finance and accounting, with excellent analytical and problem-solving skills.The Senior Financial Specialist will be responsible for providing...