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Principal Clinical Trial Regulatory Affairs

Location :

Vila Hamburguesa, SP, Brazil

Job ID :

25001569-OTHLOC-7341-2DR

Overview

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 brings the customer and the patient to the center of everything that we do.

We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.

We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know :

WORK HERE MATTERS EVERYWHERE

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.

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.

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 including plan updates, controlled document requirements and other 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).

Coordinate and / or perform regulatory core submission (including 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 regulatory considerations (e.g., RFIs) during submission review.

When required, employ regulatory writing skills to author regulatory documents for submissions.

Prepare the core clinical trial application dossier for amendments / modifications during lifecycle maintenance of the projects.

Perform Regulatory Impact Assessment on core amendment submission documents and communicates risk mitigation to Sponsor / Project teams; oversee review for 2nd level to identify gaps and risks.

Identify gaps in the evidence base supporting submissions and contribute to the development of regulatory recommendations and decisions.

Reviews the project budget against milestones and budget to ensure project profitability.

Uses planning tools for scope management and ensures budget management; notify Site Activation Management of out-of-scope work.

Acts as liaison between customer leaders and senior management relating to regulatory tasks and issues.

Explain complex regulatory issues in plain language to nontechnical audiences.

Lead regulatory activities for projects with high regulatory complexity as Regulatory Subject Matter Expert with major functional area leads.

Facilitate processes and communications within the CTRA Team.

Contribute to development of new business opportunities where possible.

Support management in reviewing and presenting information at project or departmental review meetings.

Develops and implements training programs for appropriate teams.

Designs presentations and delivers information accessibly; develops basic training courses and transfers knowledge to entry-level employees.

Ensure personal compliance with quality standards and maintain current knowledge of applicable regulations and guidelines.

Qualifications

Bachelor's Degree; Higher Degree preferred.

Subject matter expertise in current regulatory frameworks (e.g., regulations and guidelines for non-interventional studies, clinical trial and medical device regulations).

Experience with GxPs (GxP, GVP, GCP, ISO 14155).

Strong knowledge of clinical research management processes, applicable regulations, drug development, and clinical project management.

Budgeting and quality management experience.

Ability to teach / mentor and coach employees; strong interpersonal and communication skills.

Quality-driven, with strong negotiating and problem-solving skills; ability to provide constructive feedback.

Demonstrated ability to explain regulatory concepts to diverse audiences; team-oriented.

Commitment to a diverse, equitable and inclusive culture.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

Discover what our more than 29,000 employees already know : work here matters everywhere.

We work hard, and smart, all in the name of getting therapies to those who need them most.

A career with Syneos Health means your everyday work improves patients' lives globally.

Syneos Health (Nasdaq : SYNH) is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.

We translate clinical and medical insights into outcomes and support a diverse, equitable and inclusive culture.

Learn more at the website we provide in plain text : syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed are not exhaustive.

The Company may assign additional tasks at its sole discretion.

Equal opportunity employer statement and other compliance text retained as required.

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