Principal Clinical Trial Regulatory Affairs - +4 years of experience in regulatory submissions in LATAM - Home Based

📋 Description

• • Serve as a pivotal Regulatory Subject Matter Expert, collaborating closely with major functional area leads to meticulously identify and evaluate critical issues within the Site Activation pathway, ensuring seamless progression of clinical trials.
• • Actively participate in strategic development activities, including engaging in high-level account and portfolio client meetings, contributing expert regulatory insights to shape project direction and client engagement.
• • Undertake significant line management responsibilities, overseeing the performance and development of direct and indirect reports. This includes, but is not limited to, participating in and managing interviewing, selection, job description preparation, professional development planning, goal setting, performance management, coaching, mentoring, employee counseling, and managing separations. You will approve courses of action for salary administration, hiring decisions, corrective actions, and terminations.
• • Develop and nurture robust, strategic relationships with clients, aligning with their assigned projects by understanding and optimizing processes and solutions, proactively assessing their evolving needs.
• • Ensure all project deliverables consistently meet and exceed both internal quality standards and customer expectations as defined by contracted deliverables. This involves providing accurate projections, comprehensive reports, timely updates, and ongoing, proactive risk assessments.
• • Work collaboratively with project leadership to define and execute strategies that meet project milestones and key deliverables. You will prepare and present the overall Regulatory strategy and status updates at client meetings, effectively communicating outcomes and action plans to the project team.
• • Assume accountability for Clinical Trial Regulatory Affairs (CTRA) operations on specific project activities, which may encompass a wide range of tasks including updating plans in accordance with Standard Operating Procedures (SOPs) and/or sponsor-scoped processes.
• • Compile all controlled document requirements and other essential elements to guarantee the delivery of high-quality, compliant regulatory documentation.
• • Prepare and/or assist in the preparation and presentation of the overall submission strategy and status at client meetings, ensuring clear communication of outcomes to the project team.
• • Conduct thorough reviews of clinical trial study core documents, such as labeling, to ensure regulatory compliance and alignment with global standards.
• • Coordinate and/or perform the compilation and submission of core regulatory documents, including but not limited to, the EU Clinical Trial Regulation Part I dossier. You will maintain study-level tracking of all submission packages.
• • Centralize and critically analyze Competent Authorities/Ethics Committees (CA/EC) regulatory considerations, including managing and responding to Requests for Information (RFIs) during the submission review process.
• • Employ effective technical and regulatory writing skills to author necessary regulatory documents for submission purposes, upon Sponsor agreement, ensuring clarity, accuracy, and compliance.
• • Prepare the core clinical trial application dossier for amendments and modifications throughout the lifecycle maintenance of projects, ensuring all regulatory requirements are met.
• • Perform detailed Regulatory Impact Assessments on core amendment submission documents, communicating any identified risks and mitigation strategies to Sponsor/Project teams. You will also oversee the second-level review for Regulatory Impact Assessments to identify gaps and highlight risk management strategies.
• • Oversee the collation, quality review, and submission of country-specific applications, ensuring adherence to local regulatory requirements.
• • Identify gaps in the evidence base supporting submissions and actively contribute to the development of strategic regulatory recommendations and decisions.
• • Review project budgets against project milestones and overall budget to ensure project profitability and financial health.
• • Utilize professionally recognized tools for planning and management of project scope, ensuring effective budget management. You will proactively notify Site Activation Management of any out-of-scope work requests and track such work until it is assigned to the backlog.
• • Act as a key liaison and facilitator between customer leaders and senior management, effectively addressing regulatory tasks and issues.
• • Translate complex technical regulatory issues into clear, understandable language for non-technical audiences, fostering broader comprehension and alignment.
• • Lead regulatory activities for projects with high complexity and significant regulatory profiles, acting as a Regulatory Subject Matter Expert in parallel with major functional area leads such as Project Management and Clinical Management.
• • Facilitate efficient processes and clear communication within the CTRA Team, promoting a collaborative and productive work environment.
• • Contribute to the development of new business opportunities by actively participating in professional conferences/seminars, strategic account/portfolio client meetings, and proposal reviews.
• • Support management in reviewing, approving, and presenting prepared information at project or departmental review meetings. You will also develop and implement training programs for appropriate departmental teams.
• • Actively participate in team meetings, designing presentations and delivering information in an engaging manner that facilitates audience understanding and interaction.
• • Design and deliver basic training courses to enhance team capabilities and knowledge transfer.
• • Utilize strong communication skills to transfer knowledge to entry-level employees, fostering their growth and development.
• • Apply technical expertise within multi-disciplinary teams, emphasizing the importance of adapting to the ever-changing regulatory environment.
• • Ensure personal compliance and accuracy with all relevant quality standards, consistently achieving and maintaining utilization targets and departmental goals.
• • Maintain current knowledge of applicable regulations and guidelines, proactively identifying relevant laws, regulations, and guidance documents covering pre and/or post-market requirements for healthcare products.