Regulatory Affairs Specialist

Há 6 dias

Brasília, Brasil Insight Global Tempo inteiro

Job Description:

The position will have primary responsibility in the Global Development Information Management team. A key responsibility of this role is to identify and recommend improvements to business processes, regulatory data, and data definitions for the RIM platform, while working in close collaboration with Global Regulatory Operations (GRO), Global Regulatory Affairs (GRA) and cross-functional stakeholders (e.g., IT, Clinical, Nonclinical, Quality). Identify opportunities within the RIM platform, to enhance compliance, efficiency, and reporting. Responsible for supporting RIM Reporting and Analytics needs across Global Regulatory Affairs as needed.

Responsibility:

  • Support efforts to align business processes to a RIM enterprise data strategy.
  • Contribute to implementation of E2E RIM which includes new system implementation, change requests, upgrades, integrations, data quality, metrics & reporting, etc.
  • Ensure user’s requirements are adequately documented and serve as the basis for system continuous improvement, process engineering/mapping, and/or new system selection.
  • Conduct training and support change management activities in RIM implementation and upgrades.
  • Track alignment of business processes and models across all business functions supporting global Regulatory product registrations.
  • Lead and/or support initiatives to integrate Regulatory information and records globally and for acquired assets and products.
  • Monitor emerging structured data standards or health agency requirements, assess business impact and define roadmap for addressing them.

Required Skills and Experience:

  • 6+ years of experience in working in a biotechnology or pharmaceutical Regulatory Affairs Operations environment
  • Experience in systems management or implementation in the life sciences industry or regulated industry.
  • Must have experience in Veeva Vault RIM
  • Other system experience preferred and may include Calyx, Lorenz, Integras, SPORIFY, and other Veeva Vaults (PromoMat, eTMF, Quality)
  • Microsoft Office and Adobe systems
  • • Knowledge of regulations, processes and industry standards and best practices that govern regulated systems, records retention and GxP


Compensation: $15/hour - $25/hr USD

  • Regulatory & Public Affairs Specialist

    1 dia atrás

    Brasília, Brasil Kaizen Gaming Tempo inteiro

    Overview Join to apply for the Regulatory & Public Affairs Specialist role at Kaizen Gaming . Kaizen Gaming , the team powering Betano, is one of the biggest GameTech companies in the world, operating in 19 markets. We always aim to leverage cutting-edge technology, providing the best experience to our millions of customers who trust us for their...

  • Regulatory & Public Affairs Specialist

    2 semanas atrás

    Brasília, Brasil Kaizen Gaming Group Tempo inteiro

    Overview Kaizen Gaming, the team powering Betano, is one of the biggest GameTech companies in the world, operating in 19 markets. We always aim to leverage cutting-edge technology, providing the best experience to our millions of customers who trust us for their entertainment. We are a diverse team of more than 2,700 Kaizeners, from 40+ nationalities...

  • Regulatory Affairs Specialist

    2 semanas atrás

    Brasília, Brasil beBeeRegulatory Tempo inteiro

    Job Overview: The primary contact with investigative sites during start-up activities and maintenance involves collecting required investigator and essential documents to ensure timely submission of EC/IRB/Third Body and Regulatory Authority applications. This role requires interaction with regulatory authorities to provide guidance on requirements and...

  • Regulatory Affairs Specialist

    1 semana atrás

    Brasília, Brasil Caderno Nacional Tempo inteiro

    Segmento: Não Informado Atividades This role requires interaction with regulatory authorities to provide guidance on requirements and maintain awareness of current standards. Maintain knowledge of regulatory legislation, guidance, and practice in assigned countries. Coordinate collection and organization of data and information required by regulatory...

  • Regulatory Affairs Associate

    Há 3 dias

    Brasília, Brasil Parexel Tempo inteiro

    **Job Description Summary** The Associate performs the assembling of submissions (post-approval changes in CTD or non-CTD format such as leaflet and packaging notification, administrative changes, renewals, Annual Reports, CMC and clinical related variations and GMP Renewals for vaccines, biological products and small molecules) and delivery of regulatory...

  • Pharmacovigilance Specialist Consultant

    46 minutos atrás

    Brasília, Brasil ClinChoice Tempo inteiro

    Job DescriptionJob Title: Senior Executive / Specialist - Case Processing Employment Type: Contract Location: Brazil (Remote) About ClinChoice ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs,...

  • Senior Regulatory Specialist

    3 semanas atrás

    Brasília, Brasil 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

    2 semanas atrás

    Brasília, Brasil 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...

  • Medical Content Specialist

    2 semanas atrás

    Brasília, Brasil beBeeContent Tempo inteiro

    Job Title: Medical Content Specialist Role Overview: As a Medical Content Specialist, you will play a pivotal role in shaping the future of AI by producing high-quality medical and scientific content for Large Language Models (LLMs). You will collaborate with AI researchers and engineers to review and refine medical-related model outputs, identify conceptual...

  • Rare Disease Specialist

    2 semanas atrás

    Brasília, Brasil Remote Jobs Tempo inteiro

    About Soleno Therapeutics IncSoleno is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of rare diseases based in Redwood City, CA.At Soleno, we are driven by the unique and multi-faceted needs of the PWS community.Like these individuals, resilience is part of who we are - it is in our...