Prin Clin Trial Reg Affairs

**Description**

JOB SUMMARY
Supports the customer-focused leadership and management of CTRA deliverables within the assigned
projects or programs. Contributes to the technical and operational aspects of the CTRA deliverables of the
assigned projects. Develops and maintains strategic relationships with customers.
Compiles core packages, completes project regulatory assessments, submission forms and uploads
documents to CTIS (Clinical Trial Information System) as required and reports progress including plans to
address potential risks/gaps to the project team, Project Manager (PM), Site Activation Management and
Project Sponsor.
JOB RESPONSIBLITIES
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 assess 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.
Develops and maintains strategic relationships with customers in alignment with their assigned projects
such as processes and solutions and proactively assesses client needs.
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:
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.
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 Requests for Information RFIs (Requests for
Information) during the submission review).
When required, employ effective technical and regulatory writing skills to author regulatory
documents for submissions purpose upon Sponsor agreement.
cycle maintenance of the projects.
Performs a Regulatory Impact Assessment on core amendment submission documents and
communicates any risk mitigation to Sponsor/Project teams and oversees review for
Regulatory Impact Assessment for 2nd level to identify gaps, highlights any risk management
to Sponsor/Project teams.
cycle maintenance of the projects. Oversees collation, quality review, and submission of
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.
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 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).
Facilita