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

Syneos Health, Inc.; Brasil; Teletrabalho; BRL 20.000 - 80.000; Tempo integral

Resumo da oferta

An established industry player is seeking a Principal Clinical Trial Regulatory Affairs expert with over 4 years of experience in regulatory submissions across LATAM, including Brazil. This role focuses on collaborating with major functional leads to streamline regulatory pathways and enhance project deliverables. The ideal candidate will have a strong background in clinical research management and regulatory compliance, along with excellent communication and problem-solving skills. Join a dynamic team dedicated to accelerating therapy delivery and making a significant impact on patients' lives.

Qualificações

• Expertise in regulatory frameworks and clinical research management.
• Experience in budgeting and quality management.

Responsabilidades

• Collaborates as Regulatory Subject Matter Expert to address Site Activation pathway issues.
• Prepares and presents overall Regulatory strategy at client meetings.

Conhecimentos

Regulatory Submissions

Clinical Research Management

Communication Skills

Negotiation Skills

Problem-Solving Skills

Formação académica

Bachelor’s Degree

Higher Degree Preferred

Descrição da oferta de emprego

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

Principal Clinical Trials Regulatory Affairs

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

Job responsibilities

1. Collaborates as Regulatory Subject Matter Expert with major functional area leads to identify and evaluate fundamental issues pertaining to the Site Activation pathway.
2. Participates in strategic development activities including account/ portfolio client meetings.
3. Line management responsibilities for staff members, including interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations.
4. Develops and maintains strategic relationships with customers in alignment with their assigned projects.
5. Ensures all project deliverables meet internal and customer expectations.
6. Works with project leadership to define the strategy to execute against milestones and key deliverables.
7. Prepares and presents overall Regulatory strategy and status at client meetings.
8. Reviews clinical trial study core documents for regulatory compliance.
9. Coordinates and performs regulatory core submissions.
10. Prepares the core clinical trial application dossier for amendments during life cycle maintenance of the projects.
11. Maintains current knowledge of applicable regulations and guidelines.

Qualifications

What we're looking for

• Bachelor’s Degree, Higher Degree Preferred.
• Subject matter expertise in current regulation frameworks.
• Experience in working to applicable GxPs.
• Strong knowledge of clinical research management processes.
• Previous experience in budgeting and quality management.
• Excellent communication and interpersonal skills.
• Strong negotiating and problem-solving skills.

Get to know Syneos Health

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway.

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to legally protected status.