- Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
- Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Review and provide feedback to management on site performance metrics.
- Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
- Inform team members of completion of regulatory and contractual documents for individual sites.
- Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
- Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
- Perform quality control of documents provided by sites.
- May have direct contact with sponsors on specific initiatives.
- 1 year clinical research experience. Equivalent combination of education, training and experience.
-
Senior Regulatory Specialist
há 4 semanas
Grupo Relaxmedic São Paulo, BrasilEstamos em busca de um profissional altamente qualificado para assumir um importante cargo de Gerência na área regulatória no Brasil. O profissional selecionado será responsável por supervisionar e coordenar as atividades relacionadas à conformidade com as normas e regulamentaçõe ...
-
regulatory affairs specialist
há 5 dias
Kenvue São Paulo, BrasilREGULATORY AFFAIRS SPECIALIST W Description Kenvue is currently recruiting for: · Regulatory Information Management (RIM) Specialist · This position reports into Manager, Global Reg Strategic Compliance and is based at Brazil.- São Paulo Capital. · Who we are · At , we real ...
-
Regulatory Affairs Specialist
há 1 dia
Edwards Lifesciences São Paulo, Brasil Tempo integralMake a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorit ...
-
Regulatory Affairs Specialist
há 1 dia
Johnson & Johnson Consumer Inc São Paulo, BrasilKenvue is currently recruiting for: Regulatory Information Management (RIM) Specialist This position reports into Manager, Global Reg Strategic Compliance and is based at Brazil.- São Paulo Capital.Who we are At Kenvue , we realize the extraordinary power of everyday care. · Buil ...
-
Regulatory Affairs Specialist
há 4 semanas
Mindray São Paulo, BrasilBe part of Mindray Brazil as Regulatory Affairs Specialist · Mindray is a Chinese multinational manufacturer of medical instruments with headquartered in Shenzhen, Guangdong. The company designs and produces medical equipment and accessories, with presence in more than 190 countr ...
-
Regulatory Affairs Specialist
há 1 dia
Kenvue São Paulo, BrasilCome work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation. · Job Description - Regulatory Data Specialist W) · Regulatory Data Specialist W · Description · Kenvue is currently recruiting for: · Regulatory Information ...
-
Regulatory Affairs Specialist
há 2 dias
Johnson & Johnson Consumer Inc São Paulo, BrasilKenvue is currently recruiting for: Regulatory Information Management (RIM) Specialist This position reports into Manager, Global Reg Strategic Compliance and is based at Brazil.- São Paulo Capital.Who we are At Kenvue , we realize the extraordinary power of everyday care.Built o ...
-
regulatory affairs junior specialist
há 1 semana
Kenvue São Paulo, BrasilREGULATORY AFFAIRS JUNIOR SPECIALIST W Description Kenvue is currently recruiting for: · Latam CMC Regulatory Affairs Jr Specialist · This position reports to Latam CMC Regulatory Affairs Manager and is based at São Paulo. · Who we are · At , we realize the extraordinary pow ...
-
Regulatory Affairs Specialist
há 3 dias
Edwards Lifesciences São Paulo, BrasilMake a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorit ...
-
Senior Regulatory Affairs Specialist
há 6 dias
Tata Consultancy Services São Paulo, SP, BrasilCome to one of the biggest IT Services companies in the world Here you can transform your career · Why to join TCS? Here at TCS we believe that people make the difference, that's why we live a culture of unlimited learning full of opportunities for improvement and mutual developm ...
-
Senior Regulatory Affairs Specialist
há 2 semanas
The BIG Jobsite Sao Paulo, BrasilProduct Steward who have the overall coordination to manage product stewardship reviews (e.G GHS regulations), existing and emerging regulations, labelling and other requirements which comprehends Latin America region. These activities may include the development of safety data s ...
-
Regulatory Specialist
há 2 semanas
Ashland Sao Paulo, BrasilAshland Inc. · Are you the kind of person that is always thinking, sketching, seeking, and adjusting? Who needs to understand how things work and then figure out how they can work better? Are you a passionate, tenacious, solver who loves to work with others who share your drive? ...
-
Regulatory Specialist
há 2 semanas
BAXTER Sao Paulo, Brasil**This is where you save and sustain lives** · At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves ...
-
Regulatory Affairs Junior Specialist
há 1 dia
J&J Brazil São Paulo, BrasilKenvue is currently recruiting for: Latam CMC Regulatory Affairs Jr Specialist This position reports to Latam CMC Regulatory Affairs Manager and is based at São Paulo .Who we are At Kenvue , we realize the extraordinary power of everyday care.Built on over a century of heritage a ...
-
Regulatory Affairs Junior Specialist
há 4 dias
Kenvue Inc São Paulo, BrasilCome work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation. · Job Description - REGULATORY AFFAIRS JUNIOR SPECIALIST W) · REGULATORY AFFAIRS JUNIOR SPECIALIST W · Description · Kenvue is currently recruiting for: · La ...
-
Senior Regulatory Affairs Specialist
há 4 semanas
Tata Consultancy Services São Paulo, BrasilCome to one of the biggest IT Services companies in the world Here you can transform your career · Why to join TCS? Here at TCS we believe that people make the difference, that's why we live a culture of unlimited learning full of opportunities for improvement and mutual developm ...
-
Regulatory Affairs Specialist LATAM
há 2 dias
Vantage Specialty Chemicals São Paulo, BrasilVantage is a leading supplier of naturally derived specialty ingredients and formulations that cater to the evolving needs of industrial and consumer markets. Through our chemistries, our customer focus and our global footprint, we are ENABLING TOMORROW'S SOLUTIONS TODAY.As a com ...
-
Regulatory Affairs Specialist
há 2 semanas
Johnson & Johnson Sao Paulo, BrasilWe are searching for the best talent for **Regulatory Affrairs Specialist** to be in São Paulo. In this role the main responsabilities are: · - Ensure registration pipeline/changes and renewals program submission is done in timely manner · - Participate in teams to execute regula ...
-
Regulatory Affairs Specialist
há 4 semanas
Mindray Greater São Paulo Area, BrasilBe part of Mindray Brazil as Regulatory Affairs Specialist · Mindray is a Chinese multinational manufacturer of medical instruments with headquartered in Shenzhen, Guangdong. The company designs and produces medical equipment and accessories, with presence in more than 190 coun ...
-
Regulatory Affairs Specialist
há 6 dias
Johnson & Johnson Sao Paulo, Brasil· Kenvue is currently recruiting for: · **Regulatory Information Management (RIM) Specialist** · This position reports into Manager, Global Reg Strategic Compliance and is based at Brazil. São Paulo Capital. · **Who we are** · At Kenvue, we realize the extraordinary power of eve ...
Regulatory Specialist 1 - São Paulo, Brasil - Iqvia Argentina
Descrição
Job OverviewPerform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.
May also include maintenance activities.Essential Functions
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.
We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.
Learn more at#J-18808-Ljbffr