Description
We are seeking a Principal Clinical Trial Regulatory Affairs to join our team in Bogota, Colombia. As a Principal Clinical Trial Regulatory Affairs, you will support the customer-focused leadership and management of CTRA deliverables within assigned projects or programs. You will contribute to the technical and operational aspects of the CTRA deliverables and develop and maintain strategic relationships with customers.
Responsibilities:
- Collaborate as Regulatory Subject Matter Expert with major functional area leads to identify and evaluate fundamental issues pertaining to the Site Activation pathway.
- Participate in strategic development activities, including account/portfolio client meetings.
- Line management responsibilities for staff members, including interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching, and mentoring.
- Develop and maintain strategic relationships with customers in alignment with their assigned projects.
- Ensure all project deliverables meet internal and customers' expectations.
- Work with project leadership to define the strategy to execute against milestones and key deliverables.
- Prepare and present overall Regulatory strategy and status at client meetings.
- Assume accountability on the CTRA operations on specific project activities.
- Updates plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes.
- Compile all controlled document requirements and other requirements to ensure quality deliverables.
- Review clinical trial study core documents.
- Coordinate and/or perform regulatory core submission.
- Centralize and perform a critical analysis of the CTA Competent Authorities/Ethics Committees CA/EC Regulatory considerations.
- Employ effective technical and regulatory writing skills to author regulatory documents for submissions purposes.
- Prepare the core clinical trial application dossier for amendments/modifications during life cycle maintenance of the projects.
- Perform a Regulatory Impact Assessment on core amendment submission documents.
- Identify gaps in the evidence base supporting submissions and contribute to the development of regulatory recommendations and decisions.
- Review the project budget against project milestones and budget.
- Use professionally recognized tools for planning and management of scope and ensure effective budget management.
- Act as liaison and facilitator between customer leaders and senior management relating to regulatory tasks and/or issues.
- Explain complex technical regulatory issues into plain language to non-technical audiences.
Qualifications:
- Bachelor's Degree, Higher Degree Preferred.
- Subject matter expertise in current regulation frameworks.
- Experience in working to applicable GxPs.
- Strong knowledge of clinical research management processes.
- Previous experience in budgeting and quality management.
- Ability to teach/mentor team members.
- Excellent communication and interpersonal skills.
- Quality-driven in all managed activities.
- Strong negotiating and problem-solving skills.