Regulatory Affairs Specialist

4 semanas atrás


São Paulo, São Paulo, Brasil Alimentiv Inc. Tempo inteiro

Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies, and the research, review and reporting on applicable global regulations and requirements. Develop stakeholder tools, process/document regulatory risk assessments, and provide support, expertise and represent the unit with other functional units, sponsors, researchers and/or regulatory authorities. Ensure high quality, timely service delivery processes are maintained in accordance with corporate, industry and regulatory standards and guidelines. May be required to coach peers and/or provide input for staff performance reviews.

Unit Management
  • Coordinate the day to day delivery of regulatory services and processes, including compilation of regulatory filings/submissions/revisions for projects, third party vendors and clinical sites.
  • Conduct or assist with regulatory and/or safety reviews, create regulatory-related tools, educational/training materials, and remain current on all aspects of clinical research regulatory requirements and industry best practices, communicating changes to project leaders in a timely manner.
Client Services
  • As the corporate subject specialist in regulatory affairs, provide regulatory, ethics and/or pharmacovigilance guidance and support to project stakeholders.
  • Represent the unit at project meetings, assisting with project education/regulatory tool development, at regulatory reviews and audits, with clients ensuring expectations are managed and met, with regulatory, ethics and government representatives and, when appropriate, respond to regulatory queries on behalf of the client.
Regulatory Strategy Development
  • Identify changes in clinical research regulatory requirements and industry best practices and recommend, implement, and maintain corporate regulatory strategies, working with other experts (safety, quality assurance) when appropriate, to meet or exceed compliance requirements of evolving regulatory initiatives.
  • Participate in specialized conferences/meetings to increase knowledge as needed.
Project Support
  • Regularly respond to registration requests and work with project teams to identify regulatory requirements.
  • Assist in the preparation of regulatory submissions and support summaries.
  • Ensure project/clinical site files and documents are developed, maintained, revised, archived and/or destroyed in accordance with project and regulatory requirements and that all project stakeholders are fully informed and trained on all applicable regulatory requirements.
Qualifications
  • Applicants should have a minimum of an undergraduate degree and 4-6 years of relevant experience in Clinical Research/Regulatory Affairs.
  • The successful candidate will possess strong knowledge of LATAM clinical trial regulations.
  • Fluency in English and Spanish (written and verbal) required.
Working Conditions
  • Home-based
  • *Accommodations for job applicants with disabilities are available upon request.
#J-18808-Ljbffr
  • Regulatory Specialist

    4 semanas atrás


    São Paulo, São Paulo, Brasil EBANX Tempo inteiro

    Build your future with Sovos. If you\'re seeking a career where innovation meets impact, you\'ve come to the right place. As a global leader, Sovos is transforming tax compliance from a business requirement to a force for growth while revolutionizing how businesses navigate the e... Regulatory Affairs Specialist We are seeking a Regulatory Affairs...


  • São Paulo, São Paulo, Brasil UBS Tempo inteiro

    Governmental & Regulatory Affairs Specialist Join to apply for the Governmental & Regulatory Affairs Specialist role at UBS Governmental & Regulatory Affairs Specialist Join to apply for the Governmental & Regulatory Affairs Specialist role at UBS Job Reference # BRJob TypeFull TimeYour roleAre you curious, have attention to detail and the ability to...


  • São Paulo, São Paulo, Brasil BOEING Tempo inteiro

    At Boeing, we innovate and collaborate to make the world a better place. From the seabed to outer space, you can contribute to work that matters with a company where diversity, equity and inclusion are shared values. We're committed to fostering an environment for every teammate that's welcoming, respectful and inclusive, with great opportunity for...


  • São Paulo, São Paulo, Brasil Smith+Nephew Tempo inteiro R$80.000 - R$120.000 por ano

    Life Unlimited.At Smith+Nephew, we design and manufacture technology that takes the limits off livingAbout The RoleImagine a role where you're not just part of the process, you redefine it. At the heart of our innovative medical devices' company, we're looking for a trailblazer to join our Regulatory Operations team in Brazil. This isn't your typical...


  • São Paulo, São Paulo, Brasil buscojobs Brasil Tempo inteiro

    Quality Assurance Regulatory Affairs ManagerJob Summary:Highridge Medical creates the world's most innovative spinal solutions across the spectrum from Motion Preservation to MIS to Bone Healing to Core Spine. Working at Highridge Medical is not just work. Life at Highridge Medical is purpose driven. Every day, you have the privilege of using your talents to...

  • Regulatory Affairs Manager

    3 semanas atrás


    São Paulo, São Paulo, Brasil Essity Tempo inteiro

    **Regulatory Affairs Manager LATAM**:**Trabalhar na Essity não é apenas uma carreira, é uma chance de tornar o mundo um lugar mais saudável, higiênico e seguro. Com inovações impactantes, juntamente com soluções sustentáveis, nos esforçamos para alcançar mais pessoas a cada ano com as soluções necessárias e essenciais para o bem-estar.****A...


  • São Paulo, São Paulo, Brasil Fortrea Tempo inteiro R$60.000 - R$120.000 por ano

    Regulatory Affairs Specialist – Global Submissions & Quality DocumentationJoin Fortrea's dynamic global team supporting pharmaceutical product development and lifecycle management. In this role, you'll be responsible for preparing, reviewing, and managing regulatory and quality documentation for submissions to health authorities across the US, EU, and...

  • Manager, Regulatory Affairs

    3 semanas atrás


    São Paulo, São Paulo, Brasil buscojobs Brasil Tempo inteiro

    Quality Assurance Regulatory Affairs ManagerJob Summary: Highridge Medical creates the world's most innovative spinal solutions across the spectrum from Motion Preservation to MIS to Bone Healing to Core Spine. Working at Highridge Medical is not just work. Life at Highridge Medical is purpose driven. Every day, you have the privilege of using your talents...


  • São Paulo, São Paulo, Brasil Johnson & Johnson Innovative Medicine Tempo inteiro R$104.000 - R$156.000 por ano

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...


  • São Paulo, São Paulo, Brasil Johnson & Johnson Tempo inteiro R$104.000 - R$156.000 por ano

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...