Principal Clinical Trial Regulatory Affairs - +4 years of experience in regulatory submissions [...]

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

• Job Responsibilities
• Collaborates as Regulatory Subject Matter Expert with major functional area leads to identify and evaluate fundamental issues pertaining to the Site Activation pathway.
• Participates in strategic development activities including account/ portfolio client meetings.
• May participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations.
• Approves courses of action on salary administration, hiring, corrective action, and terminations.
• Reviews and approves time records, expense reports, requests for leave, and overtime.
• Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.
• Develops and maintains strategic relationships with customers in alignment with their assigned projects such as processes and solutions and proactively assesses client needs.
• Ensures all project deliverables meet the internal and customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments.
• Works with the project leadership to define the strategy to execute against milestones and key deliverables; prepares and presents overall Regulatory strategy and status at client meetings and communicates outcomes to project team.
• Assumes accountability on the CTRA operations on specific project activities which may include but are not limited to: updating plans in accordance with Standard Operating Procedures and/or sponsor‑scoped processes; compiling all controlled document requirements and other requirements to ensure quality deliverables.
• Prepares/assists and presents overall submission strategy and status at client meetings and communicates outcomes to project team.
• Reviews clinical trial study core documents (such as labelling for regulatory compliance etc.).
• Coordinates and/or performs regulatory core submission (including for example EU Clinical Trial Regulation Part I dossier); performs study level tracking of the submission packages.
• Centralizes and performs a critical analysis of the CTA Competent Authorities/Ethics Committees CA/EC Regulatory considerations (such as Requests for Information RFIs during the submission review).
• Employs effective technical and regulatory writing skills to author regulatory documents for submissions purpose upon Sponsor agreement; prepares the core clinical trial application dossier for amendments/modifications during life cycle maintenance of the projects.
• Performs a Regulatory Impact Assessment on core amendment submission documents and communicates any risk mitigation to Sponsor/Project teams; oversees review for Regulatory Impact Assessment for 2nd level to identify gaps, highlights any risk management to Sponsor/Project teams.
• Prepares the core clinical trial application dossier for amendments/modifications during life cycle maintenance of the projects; oversees collation, quality review, and submission of country‑specific applications.
• Updates plans in accordance with Standard Operating Procedures and/or sponsor‑scoped processes.
• Compiles all controlled document requirements and other requirements to ensure quality deliverables.
• Identifies gaps in the evidence base supporting submissions and contributes to the development of regulatory recommendations and decisions.
• Reviews the project budget against project milestones and budget to ensure project profitability.
• Uses professionally recognized tools for planning and management of scope and ensures effective budget management; if out‑of‑scope work is requested, notifies the Site Activation Management and tracks out‑of‑scope work until it is assigned to backlog.
• Acts as liaison and facilitator between customer leaders and senior management relating to regulatory tasks and/or issues.
• Explains complex technical regulatory issues into plain language for non‑technical audiences.
• Is accountable in parallel to lead regulatory activities for projects having high complex regulatory profile as Regulatory Subject Matter Expert with major functional area leads (Project Management, and Clinical Management).
• Facilitates processes and communications within the CTRA Team.
• May contribute to development of new business opportunities whenever possible (e. g., while in attendance at professional conferences/seminars); participates in development activities including strategic account/ portfolio client meeting and/or reviews of proposals.
• Supports management in reviewing, approving, and presenting prepared information at project or departmental review meetings.
• Develops and implements training programs for appropriate departmental teams; actively participates in team meetings.
• Designs presentations and delivers information in a way that allows the audience to understand the information and interact appropriately; designs and delivers basic training courses.
• Uses communication skills to transfer knowledge to entry‑level employees; applies technical expertise in multi‑disciplinary teams and explains the importance of adapting to the changing regulatory environment.
• Ensures personal compliance and/or accuracy with relevant quality standards; consistently achieves and maintains utilization target and departmental goals.
• Maintains current knowledge of applicable regulations and guidelines; identifies relevant laws, regulations, and guidance documents covering pre and/or post‑market requirements for healthcare products.

Qualifications

• Bachelor’s Degree, Higher Degree Preferred.
• Subject matter expertise in current regulation frameworks (e. g., regulations and guidelines specific for non‑interventional studies, clinical trials, and medical device regulations).
• Experience in working to applicable Gx Ps (e. g., GVP, GCP, ISO 14155).
• Strong knowledge of clinical research management processes. Thorough knowledge of applicable regulations, drug development, and clinical project management procedures.
• Previous experience in budgeting and quality management.
• Ability to teach/mentor team members.
• Ability to coach employees to reach performance objectives.
• Ability to recognize and take appropriate action when employee performance is not acceptable.
• Excellent communication and interpersonal skills (both written and spoken) with an ability to influence, convince and persuade as well as a team‑oriented approach.
• Quality‑driven in all managed activities.
• Strong negotiating and problem‑solving skills.
• Demonstrates an ability to provide quality feedback and guidance to peers.
• Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.

The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.

Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.

The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.

Further, nothing contained herein should be construed to create an employment contract.

Occasionally, required skills/experiences for jobs are expressed in brief terms.

Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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