Principal Clinical Trial Regulatory Affairs

Principal Clinical Trial Regulatory Affairs - +4 years of experience in regulatory submissions in LATAM - Argentina, Mexico or Brazil. Home Based.

• 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.
• Line management responsibilities for staff members. For direct and indirect reports, 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.
• Work 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 not limited to update plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes. Compiles 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.
• Review clinical trial study core documents (such as labelling for regulatory compliance etc.). Coordinate and/or perform regulatory core submission (including for example EU Clinical Trial Regulation Part I dossier). Perform study level tracking of the submission packages.
• Centralize and perform a critical analysis of the CTA Competent Authorities/Ethics Committees CA/EC Regulatory considerations (such as RFIs during the submission review).
• When required, employ 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. Oversees collation, quality review, and submission of country-specific applications.
• Identify gaps in the evidence base supporting submissions and contribute 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 back log.
• Acts 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 nontechnical audiences.
• Accountable 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 when possible including participation in professional conferences/seminars, strategic account/portfolio client meetings and 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. Designs presentations and delivers information in a way that is understandable. Ensures personal compliance with relevant quality standards and maintains utilization targets.
• Maintains current knowledge of applicable regulations and guidelines; identifies laws, regulations, and guidance documents for pre and/or post-market requirements for healthcare products.

• Bachelor's Degree, Higher Degree Preferred.
• Subject matter expertise in current regulation frameworks (e.g. regulations and guidelines specific for non-interventional studies, clinical trial and medical device regulations).
• Experience in working to applicable GxPs (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 and coach employees to reach performance objectives.
• Excellent communication and interpersonal skills; ability to influence, convince and persuade; team-oriented approach.
• Quality-driven in all managed activities; strong negotiating and problem-solving skills.
• Demonstrate ability to provide quality feedback and guidance to peers.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers the customer and the patient. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

We are 29,000 employees across 110 countries committed to a Total Self culture that supports authentic selves and cares for our people.

• Full-time