Regulatory Affairs Specialist

Há 2 dias

Rio de Janeiro, Rio de Janeiro, Brasil Alimentiv Tempo inteiro
Overview

Regulatory Affairs Specialist (LATAM) 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.

Responsibilities
  • 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.
  • 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.
  • 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.
  • 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.
Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Legal
Industries
  • Pharmaceutical Manufacturing
#J-18808-Ljbffr

  • Regulatory Affairs Professional

    Há 4 horas

    Rio de Janeiro, Rio de Janeiro, Brasil beBeeRegulatoryAffairs Tempo inteiro R$90.000 - R$110.000

    Enhance public health through innovative solutions in a dynamic regulatory environment.Regulatory Affairs SpecialistThe Regulatory Market team is seeking a skilled Regulatory Affairs Specialist to support Latin America and Canada region. This role involves close collaboration with local teams to ensure product compliance across the region.Key...

  • Regulatory Affairs Governance Professional

    1 dia atrás

    Rio de Janeiro, Rio de Janeiro, Brasil beBeeSpecialist Tempo inteiro R$90.000 - R$120.000

    Regulatory Affairs SpecialistThis role requires an individual with a deep understanding of regulatory frameworks and the ability to develop integrated policy and advocacy strategies to drive business objectives. As a Regulatory Affairs Specialist, you will be responsible for creating and executing plans to improve regulatory environments, engage with key...

  • Regulatory Affairs Specialist

    Há 6 dias

    Rio de Janeiro, Rio de Janeiro, Brasil beBeeRegulatory Tempo inteiro US$85.000 - US$110.000

    Job OverviewThis is an exciting opportunity to join our Regulatory Affairs team as a highly motivated and experienced professional. As a key member of our team, you will be responsible for maintaining all Marketing Authorizations valid in Brazil, registering new products while monitoring and updating on Brazilian health regulations daily. Main...

  • Compliance Specialist

    Há 4 horas

    Rio de Janeiro, Rio de Janeiro, Brasil beBeeRegulatory Tempo inteiro R$120.000 - R$150.000

    Our company is seeking a highly skilled Technical Regulatory Specialist to join our dynamic team.About the RoleThe primary responsibility of this position will be to ensure that regulatory compliance assessment and monitoring processes are in place, guaranteeing our operations meet the highest industry standards.Key Responsibilities:We require regular...

  • Pharmaceutical Regulatory Specialist

    1 dia atrás

    Rio de Janeiro, Rio de Janeiro, Brasil beBeeDiversity Tempo inteiro R$90.000 - R$123.000

    Regulatory Affairs Analyst RoleAs a key member of our Regulatory Affairs team in Rio de Janeiro, Brazil, you will play a vital role in supporting the management of regulatory priorities and assessments.Key Responsibilities:Support the management in orienting, training, and supervising analysts and trainees in the CRA team and members from the Hub dedicated...

  • Regulatory Affairs Advisor

    2 semanas atrás

    Rio de Janeiro, Rio de Janeiro, Brasil Shell Tempo inteiro

    **The Role**:**Company description**As a global energy company operating in a challenging world, we set high standards of performance and ethical behaviors. We are judged by how we act and how we live up to our core values of honesty, integrity, and respect for people. Our Business Principles are based on these. They promote trust, openness, teamwork, and...

  • Expert Clinical Trial Coordinator

    1 dia atrás

    Rio de Janeiro, Rio de Janeiro, Brasil beBeeRegulatory Tempo inteiro R$80.000 - R$120.000

    Job Title: Regulatory Affairs Specialist">Key Responsibilities:Coordinate the delivery of regulatory services, including compilation of filings/submissions/revisions for projects and third-party vendors.Conduct or assist with regulatory and safety reviews, create regulatory tools and materials, and remain current on clinical research regulatory...

  • Senior Regulatory Strategy Specialist

    1 semana atrás

    Rio de Janeiro, Rio de Janeiro, Brasil beBeeRegulatory Tempo inteiro R$80.000 - R$130.000

    Job DescriptionWe are seeking a seasoned professional to fill the role of Regulatory Affairs Advisor. As a key member of our team, you will be responsible for developing and implementing regulatory strategies that align with our business objectives.The ideal candidate will have a strong understanding of domestic and regional regulatory environments, as well...

  • Senior Regulatory Affairs Coordinator

    Há 4 dias

    Rio de Janeiro, Rio de Janeiro, Brasil beBeeRegulatory Tempo inteiro R$100.000 - R$120.000

    Key Responsibilities:Maintain regulatory awareness, ensuring up-to-date knowledge of applicable laws and guidelines.Coordinate the collection and organization of data and information required by regulatory authorities, including the preparation of study documentation such as country application forms and cover letters.

  • Regulatory Affairs, Study Start Up Specialist

    Há 7 dias

    Rio de Janeiro, Rio de Janeiro, Brasil Mexico Tempo inteiro

    **ALL CV ´s MUST BE SUBMITTED IN ENGLISH IN ORDER TO BE CONSIDERED****Essential Functions**:- Assist/Advise project teams on all regulatory requirements for clinical studies- Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings- Review and adapt study specific...