Principal Clinical Trial Regulatory Affairs
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Job Description
Regulatory Subject Matter Expert focusing on regulatory submissions for clinical trials in LATAM region. Collaborating with teams to ensure compliance and efficient processes.
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 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 labeling 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).
Requirements:
- +4 years of experience in regulatory submissions in LATAM
- 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) etc.
- 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.
- Demonstrate an ability to provide quality feedback and guidance to peers.
Benefits:
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to building an inclusive culture – where you can authentically be yourself.
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