Regulatory Affairs

Há 1 mês

são paulo, Brasil Intrials Clinical Research Tempo inteiro

Location: Brazil


Who We Are


Science as a tool. People as inspiration.


Intrials is a disruptive company with all the attributes that a CRO must master. We mix innovative projects with the necessary skills to provide a full service. Nothing stops us in the search for knowledge. Transforming people's lives through science tackling the challenges of our clients' projects in a focused and exclusive fashion.


People are indeed our main asset. We work tirelessly to pilot and monitor Clinical Research projects since the beginning. We guarantee connection, innovation, and security in solutions for the entire health chain.


Diversity & Inclusion are essential to continue building our history of innovation. Diversity of color, belief, sexual orientation, religion, or any other characteristic are very welcome in all open positions at our company. It is a fundamental part of Intrials to constantly think and implement actions that reinforce the importance of good coexistence with all the people who are part of our DNA and together, to leverage and build true impactful results in our society.


All about people, purpose and science.


Primary responsibilities include, but are not limited to:


  • Management of part of the Regulatory & Study Start-up team in all aspects with support of Regulatory and Study Start-up Manager (RSM);
  • Support RSM on defining metrics and KPIs for the Regulatory & Study Start-up department;
  • Support RSM on preparing and maintaining financial projections (forecasts) and monitor results;
  • Support RSM on preparing and maintaining resources projections (forecasts);
  • Define staff allocation for regulatory and start-up activities to PMs, and discuss allocation with PMs;
  • Provide support / mentoring / coaching / training to the Regulatory & Study Startup team involved in the clinical trials;
  • Ensure that Regulatory & Study Start-up team conducts clinical trials in accordance with the ICH-GCP guidelines, local and international regulations as well as following Intrials’ and Sponsor’s SOPs, as applicable;
  • Ensure the clinical trials regulatory and start-up activities follow the forecasted activities, timelines, milestones and contract budget;
  • Member of ABRACRO (CRO Brazilian Association) and/or CTNBio in Brazil, if required;
  • Participate in RFPs development and attend at bid defense meetings, if required;
  • Act as Intrials governance point of communication for the Sponsor during project development and conduction, with RSM support;
  • Might act as the point of contact with sponsor during project development, start-up and maintenance for regulatory and start-up procedures (but might only be aligned with the Lead CRAs and/or Project Managers);
  • Might be responsible for the definition of regulatory and start-up strategies with sponsors, aligned with the Lead CRAs and/or Project Managers;
  • Manage LATAM countries regulatory deliverables and activities during project development, start-up and maintenance with close communication with internal team, sponsor, sites and vendors;
  • Might prepare, review and perform ethics and regulatory submissions /activities during project start-up and maintenance with close communication with internal team, sponsor, sites and vendors.


Primary responsibilities include, but are not limited to:


  • Support RSM on preparing and maintaining projections (forecasts) and monitor results;
  • Support RSM on preparing and maintaining resources projections (forecasts);
  • Define staff allocation for regulatory and start-up activities to PMs, and discuss allocation with PMs;
  • Check regularly the study metrics and milestones to guarantee that the projects are being conducted according to the Sponsor requirements;
  • Keep regular contact with PMs, RSAs, COM, and BDM;
  • Organize / conduct department meetings with study teams at regular basis and whenever needed;
  • Conduct of regular one to one meetings and performance evaluation;
  • Oversee the Clinical Trials regulatory and start-up activities;
  • Oversee study safety reports management, when applicable.
  • Analyze and anticipate risks - ensure they are mitigated with robust action plans in place as agreed with PM, QAM, COM and / or the Sponsor;
  • Provide support to PMs on regulatory and start-up strategies, when required;
  • Assist in the creation and revision of the SOPs related to the department activities;
  • Support team during Audits and CAPAs;
  • Assist PM to prepare project revenue and forecast activities in the project financial control;
  • Analyze risks and anticipate/identify potential problems; ensure they are mitigated/solved with robust action plans in place as agreed with PM, QAM and / or Sponsor;
  • Shares lessons learned and ensures adequate deployment of possible identified action plans for local and region improvement;
  • Provide training, feedback, and support for Regulatory & Study Start-up team in Latin America;
  • Sites, sponsors, brokers, and regulatory agencies communication for problem resolution;
  • Support Business Development department on regulatory knowledge for RFPs, contract updates and bid defense meetings;
  • Might act as the point of contact with sponsor during project development, start-up and maintenance for regulatory, start-up procedures (but might only be aligned with the Lead CRAs and/or Project Managers);
  • Might be responsible for the definition of regulatory and start-up strategies with sponsors, aligned with the Lead CRAs and/or Project Managers;
  • Might manage LATAM countries regulatory deliverables and activities during project development, start-up and maintenance with close communication with internal team, sponsor, sites and vendors;
  • Might prepare, review and perform ethics and regulatory submissions / activities during project start-up and maintenance with close communication with internal team, sponsor, sites and vendors;
  • Perform interviews and staff hiring;
  • Participate in local and / or international meetings / courses in order to improve /acquire new skills;
  • Work in compliance with applicable SOPs, Work Instructions, local and international regulations, and Good Clinical Practices (ICH-GCP).


Requirements:


  • University Degree in any area related to Health area (Pharmacist, Nursery, etc.)
  • Solid professional experience working in Regulatory and Start-up activities for Clinical Trials in pharmaceutical companies or CROs
  • Good knowledge of clinical trials local and international regulations applicable to Latin America where Intrials has offices;
  • Professional experience with clinical trials procedures for studies phases I-III and ICH-GCP;
  • Professional experience with country regulations for LECs, MOH and other regulatory bodies applicable for clinical trials approval;
  • High Intermediate or Advanced English;
  • Spanish will be considered an advantage;
  • Knowledge of Microsoft Office, Excel and Adobe Acrobat software.

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