Principal Clinical Trial Regulatory Affairs - +4 years of experience with multiple countries regulatory submissions - Colombia Hybrid

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

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 deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health
• 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. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

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.

Responsibilities:

Collaborates as Regulatory Subject Matter Expert with major functional area leads to identify and evaluate fundamental issues pertaining to the Site Activation pathway.
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Participates in strategic development activities including account/ portfolio client meetings.
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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.
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Develops and maintains strategic relationships with customers in alignment with their assigned projects such as processes and solutions and proactively assess client needs.
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Ensures all project deliverables meet the internal and customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments.
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Develops and maintains strategic relationships with customers in alignment with their assigned projects such as processes and solutions and proactively assesses client needs.
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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.
- Prepares the core clinical trial application dossier for amendments/modifications during life 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.
- 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.
- 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).
Facilitates processes and communications within the CTRA Team.
- May contribute to development of new business opportunities whenever possible (e.g., while in attendance at professional conferences/seminars), participates in development activities including strategic account/ portfolio client meeting and/or 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. Actively participate in team meetings. Designs presentations and delivers information in a way that allows the audience to understand the information and interact appropriately. Designs and delivers basic training courses.
- Use communication skills to transfer knowledge to entry-level employees. Apply technical expertise in multi-disciplinary teams and explain the importance of adapting to the changing regulatory environment.
Ensure personal compliance and/or accuracy with relevant quality standards. Consistently achieve and maintain utilization target and departmental goals
Maintains current knowledge of applicable regulations and guidelines. Identify relevant laws, regulations, and guidance documents covering pre and/or post-market requirements for healthcare products.

Qualifications:

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.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

About the company

Syneos Health provides end-to-end biopharmaceutical solutions across the clinical-to-commercial spectrum. It helps biopharma companies, healthcare organizations, and investors by offering specialized expertise, insights, and technology-enabled services to move therapies faster to patients. Its offerings include Kinetic, a modern omnichannel customer engagement platform that uses targeting and analytics to coordinate nationwide healthcare communications, and Syneos One, an asset development approach that aligns strategy and execution from early concept through commercialization. The company uses AI and advanced tech to improve performance and reduce risk in drug development and market delivery. Its goal is to be a trusted partner that accelerates therapy development and delivery by combining scientific know-how with integrated, data-driven services.

Company Size

10,001+

Company Stage

IPO

Headquarters

Morrisville, North Carolina

Founded

1985

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Simplify's Take

What believers are saying

KAI partnership on April 30, 2026 expands commercial intelligence for U.S. pharma launches.
Syneos says Causaly cut study-design insight time roughly 50% in 2026.
Databricks reduced source-data review from days to hours, speeding trial interventions.

What critics are saying

March 31, 2026 Kempen discovery keeps securities-fraud claims alive over backlog reporting.
Syneos Italy announced 49 layoffs on March 25, 2026, signaling operating pressure.
A sustained data-integrity finding in Kempen would damage sponsor trust and trigger defections.

What makes Syneos Health unique

Syneos combines clinical development and commercialization under one roof, unlike pure-play CROs.
August 18, 2026 AI stack spans Causaly, Databricks, and Microsoft across workflows.
More than 280 Microsoft Copilot agents give Syneos broad internal automation depth.

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Benefits

Health Insurance
Dental Insurance
Vision Insurance
401(k) Company Match
Employee Stock Purchase Plan
Flexible Work Hours
Paid Vacation
Paid Sick Leave
Remote Work Options

Company News

GlobeNewswire

Oct 20th, 2026

Optum and Syneos Health partner to advance an adaptive Clinical Development model.

Optum and Syneos Health partner to advance an adaptive Clinical Development model. Partnership Will Transform How Clinical Development is Designed and Executed MORRISVILLE, N.C., Oct. 20, 2026 (GLOBE NEWSWIRE) - Syneos Health(R) today announced a partnership with Optum to build a more adaptive and connected model for clinical development, helping biopharmaceutical companies deliver promising therapies to patients sooner. The collaboration will bring together Optum's healthcare industry knowledge, specialized expertise and AI resources with Syneos Health's clinical development expertise, global trial operations and technology solutions. The resulting model is designed to strengthen development strategies and execute more precise, efficient trials by improving recruitment and trial performance, reducing operational complexity and enhancing predictability across development timelines and costs. Under the agreement, Syneos Health and Optum will partner closely in the development of: * Adaptive clinical development planning to enable development teams to simulate trial scenarios, evaluate protocol assumptions, identify possible risks and assess interventions before and during trial implementation. * Patient, site and investigator access to help clinical trial sponsors more easily identify eligible patient populations to expand patient access and optimize locations so trials can begin faster. Syneos Health will be Optum's preferred partner for the development of their site management organization (SMO). * Data, technology and governance infrastructure to responsibly scale these improvements while maintaining rigorous standards for scientific validation, privacy, evidence traceability and human oversight. "Clinical development is at an inflection point. The future belongs to organizations that can connect data, human expertise and AI technology to make better decisions faster," said Costa Panagos, Chief Executive Officer of Syneos Health. "Our collaboration with Optum brings deep healthcare expertise that can help improve trial design and implementation with greater precision and predictability." "Clinical research is one of the most complex and data-intensive activities in healthcare, yet necessary connections are fragmented all too often," said Sandeep Dadlani, Chief Executive Officer of Optum Insight. "By connecting our responsible use of technology and network with Syneos Health's global clinical development capabilities, we can make the health system work better for everyone." This announcement builds on Syneos Health's broader commitment to shape the future of clinical development. As part of its AI ecosystem, the Company continues to invest in technologies and collaborations that enhance decision-making, streamline execution and unlock new value from clinical and real-world data. Recent initiatives have included expanding agentic solutions that connect insights, workflows and expertise across operations. About Syneos Health Syneos Health(R) is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, commercial and real world insights into outcomes to address modern market realities. We bring together a talented team of professionals with a deep understanding of patient and physician behaviors and market dynamics. Together we share diverse insights, use the latest technologies and apply advanced business practices to speed our customers' delivery of important therapies to patients. Syneos Health is powered by an authentic, inclusive and high-performance culture that cares for colleagues, customers, patients, communities and the environment. About Optum Optum is a leading information and technology-enabled health services business dedicated to helping make the health system work better for everyone. With more than 310,000 people worldwide, Optum delivers intelligent, integrated solutions that help to modernize the health system and improve overall population health. Optum is part of UnitedHealth Group (NYSE: UNH). For more information, visit www.optum.com. Press/Media Contact: Meg Byers Director, External Communications [email protected]

TransportTalk

Aug 31st, 2026

Teletrac Navman appoints Sara Epstein to senior leadership role.

Teletrac Navman appoints Sara Epstein to senior leadership role. Reading Time: 2 mins read Teletrac Navman has appointed Sara Epstein as chief legal and administrative officer as the connected mobility business enters its next phase of growth. Epstein brings more than 20 years of legal and executive leadership experience across sectors including healthcare, life sciences, pharmacy and logistics. She will oversee Teletrac Navman's legal, compliance, data privacy and governance functions, along with People and Culture and Health and Safety. Epstein was previously chief legal officer at pharmacy benefits company RxBenefits and executive vice president and deputy general counsel at Syneos Health, where she led a global team responsible for legal and privacy services. She has also held senior legal roles at Cotiviti Holdings and BlueLinx Holdings and was an associate at international law firm Jones Day. Teletrac Navman President and chief executive Alain Samaha says Epstein's experience will support the company's strategic and growth plans. "Sara brings a powerful combination of legal acumen, business judgment and executive leadership that will help accelerate our strategic initiatives and support our long-term growth," Samaha says. "Her experience leading global teams and navigating complex business environments will be instrumental as we continue to drive innovation, strengthen our customer relationships and execute on our growth ambitions. We're thrilled to welcome her to the team." The appointment follows Teletrac Navman's acquisition by Respida Capital earlier this year and a series of product developments, including the launch of Energy Hub within its TN360 fleet management platform and the company's Electronic Braking Performance Monitoring System. "I'm excited to join Teletrac Navman at such an important time in the company's evolution," Epstein says. "The organisation has a strong foundation, a talented global team, and a clear vision for growth. I look forward to working across the business to support our strategic priorities and contribute to the next chapter of Teletrac Navman's success." Epstein holds a Juris Doctor from Tulane University Law School and a bachelor's degree from Tufts University.

HR TODAY

Aug 26th, 2026

Madhuri Raya joins Syneos Health as Global Head, AI & Engineering and Technology Capability Center.

Madhuri Raya joins Syneos Health as Global Head, AI & Engineering and Technology Capability Center. Hyderabad, Telangana, India, August 2026 - Syneos Health has appointed Madhuri Raya as Global Head, AI & Engineering and Technology Capability Center, strengthening its technology leadership as the organisation accelerates its AI-enabled strategy. In her new mandate, Raya will focus on scaling engineering capabilities behind Syneos Health's growing AI ecosystem and helping translate technology innovation into practical solutions for biopharmaceutical development. Raya brings more than two decades of experience across software engineering, product engineering, cloud-native technologies, AI/ML-enabled solutions and global engineering leadership. She joins Syneos Health after a long tenure with Optum, where she most recently served as Vice President of Software Engineering. During more than eight years with the organisation, she progressed through senior technology leadership positions, including Director of Product Engineering and Senior Director - Product Engineering. Before Optum, Raya spent more than five years with UnitedHealth Group, serving as Engineering Manager and subsequently Senior Engineering Manager. These roles added to her experience in leading engineering organisations within the healthcare ecosystem and managing increasingly complex technology responsibilities. Earlier in her career, Raya spent more than a decade with the Robert Bosch Research and Technology Center. She worked initially as a Software Engineer before progressing to Senior Research Engineer, a position she held for more than seven years. This foundation in software engineering and research, followed by leadership roles across healthcare technology and product engineering, has shaped a career spanning technical innovation and large-scale engineering management. At Syneos Health, Raya joins at a time when the company is expanding the role of AI and technology across its operations. Her mandate will center on strengthening the engineering capabilities supporting this strategy, bringing together AI, engineering and technology delivery to improve agility, precision and intelligence in addressing customer challenges. She is an alumna of the Birla Institute of Technology and Science, Pilani (BITS Pilani). Syneos Health is a fully integrated biopharmaceutical solutions organisation focused on accelerating customer success. The company combines clinical, commercial and real-world insights to help address evolving market needs and support the delivery of therapies to patients. Its professionals bring together knowledge of patient and physician behaviours, market dynamics, technology and advanced business practices. Syneos Health positions technology and cross-functional expertise as important enablers in helping customers advance the development and commercialisation of therapies.

Applied Clinical Trials

Aug 19th, 2026

Syneos Health expands AI ecosystem with three new platform partnerships.

Syneos Health expands AI ecosystem with three new platform partnerships. New collaborations with Causaly, Databricks, and Microsoft anchor a broader push to embed artificial intelligence directly into clinical trial decision-making and operational workflows. "When technology is applied precisely at critical decision points, teams can anticipate risk earlier to accelerate development." Syneos Health has announced the continued expansion of its artificial intelligence (AI) ecosystem, detailing three platform partnerships designed to embed AI into core clinical development workflows.[1] The three partnerships each target a distinct layer of the clinical development stack. Through a new collaboration with Causaly, Syneos is applying agentic, evidence-based scientific reasoning to accelerate protocol strategy development, feasibility planning, and competitive trial intelligence. Causaly's platform surfaces evidence from a proprietary knowledge graph combining biomedical research and commercial insights. According to the company, the integration has reduced the time it takes to derive insights for study strategy and design by approximately 50%. The partnership with Databricks focuses on the data infrastructure layer. By leveraging the Databricks Data and AI Platform, Syneos has developed a near real-time view of clinical operations that reduces the time from source data capture to review-ready insight from days to hours, enabling faster intervention and more efficient trial execution. The Microsoft collaboration, which builds on a relationship that began in 2023, extends AI adoption through productivity and workflow tools. Syneos has used Microsoft Power Apps and other tools to develop more than 280 agents that integrate with Microsoft 365 Copilot to streamline workflows and support faster decision-making across the organization. "When technology is applied precisely at critical decision points, teams can anticipate risk earlier to accelerate development," said Mike Montello, chief digital and information officer at Syneos Health, in a company press release. Together, the three partnerships are designed to create what Syneos Health describes as a unified intelligence environment - connecting operational, clinical, and real-world data across the development lifecycle. The company noted that all capabilities are deployed with human oversight and governance to ensure responsible use in regulated environments. A broader conversation about AI and site readiness. The Syneos announcement reflects a pattern Applied Clinical Trials has been tracking closely: sponsor investment in AI is accelerating, but questions about how that technology reaches sites - and whether it actually fits their workflows - remain unresolved. In a recent with ACT, Liz Beatty, co-founder and chief strategy officer at Inato, addressed that tension directly.[2] Beatty argued that the industry has consistently made the mistake of building technology for sponsors rather than for sites. "We need to stop, and instead think: how can I enable sites to use this technology to become more efficient and effective in clinical trials, which then helps my trial and my company - not the other way around," she said. On where AI is delivering measurable enrollment impact, Beatty pointed to real-time patient data as the most significant shift. Rather than relying on feasibility questionnaires and sponsor-discounted estimates, AI tools can now identify which specific patients at a given site currently meet study criteria. In a chronic obstructive pulmonary disease case study, than those that did not, and 100% of sites using the tool were able to successfully screen and enroll patients. Looking ahead, Beatty pointed to a structural shift she sees gaining momentum: sponsors moving away from trial-by-trial site planning toward program or cross-asset planning, building deeper site partnerships across multiple studies. This represents a dynamic that could meaningfully change how enrollment bottlenecks are addressed before a trial even begins. References

News Break! Middle East

Aug 18th, 2026

Syneos Health advances ai-powered clinical ecosystem to optimize trial performance and speed decision-making.

Syneos Health advances ai-powered clinical ecosystem to optimize trial performance and speed decision-making. Expanding set of partners and proprietary insights strengthens operational performance. MORRISVILLE, N.C., Aug. 18, 2026 (GLOBE NEWSWIRE) - Syneos Health(R), a leading fully integrated biopharmaceutical solutions organization, today announced the continued advancement of its AI ecosystem - a unified, enterprise approach that embeds artificial intelligence (AI) directly into the core of clinical development. By combining deep therapeutic expertise, healthcare professional intelligence and modern AI technologies, Syneos Health is helping sponsors navigate an increasingly complex development landscape. Grounded in decades of clinical and commercial experience, Syneos Health's differentiated AI approach focuses on integrating advanced capabilities into critical decision points across protocol design, feasibility, enrollment planning, site activation, monitoring and operational oversight. This enables teams to anticipate risk earlier, reduce friction across workflows and make faster, more informed decisions that improve study performance. "Our priority is AI that works inside the complexity of clinical trials. By combining advanced AI with a deep understanding of sites, physicians, patients and the operational dynamics that shape trial performance, we're unlocking new opportunities for speed, clarity and quality," said Mike Montello, Chief Digital and Information Officer, Syneos Health. "When technology is applied precisely at critical decision points, teams can anticipate risk earlier to accelerate development." Enterprise AI and Data Platforms Syneos Health is building a future ready ecosystem bringing together capabilities combining scientific expertise, connected data and evidence, and AI-enabled execution. This integrated approach creates a unified intelligence environment that enables faster, more informed decisions across the clinical development lifecycle. * Causaly - Syneos Health's new collaboration with Causaly applies agentic, evidence-based scientific reasoning to enable faster protocol strategy development, feasibility planning and competitive trial intelligence. Built specifically for the life sciences sector, Causaly's Agentic Research surfaces evidence from a proprietary knowledge graph combining biomedical research and commercial insights. By accelerating analysis of complex biomedical literature and emerging data, Syneos Health teams have reduced the time it takes to derive insights for study strategy and design by approximately 50%. * Databricks - Using Databricks enables Syneos Health to create a more powerful, unified intelligence environment that brings together operational, clinical and real-world data to advance modern clinical development. Leveraging the Databricks Data + AI Platform, Syneos Health has developed a continuous, near real-time view of clinical operations that reduces the time from source data capture to review-ready insight from days to hours, enabling faster intervention and more efficient trial execution. * Microsoft - Building on its long-standing collaboration that began in 2023, Syneos Health is driving AI adoption through its integration with Microsoft. Specifically, Syneos Health has used Microsoft Power Apps and other tools to develop more than 280 agents that integrate with Microsoft 365 Copilot to improve productivity, streamline workflows and support faster, more confident decision-making across the company. Complementing these foundational capabilities are frontier agentic AI solutions and proprietary Syneos Health insights embedded directly within clinical workflows. Together, they help improve predictability, reduce operational complexity, and drive more precise, scalable trial performance. These capabilities are deployed with strong human oversight and governance, ensuring responsible use in regulated environments. "What differentiates Syneos Health is our ability to redesign how clinical development decisions are made through the combination of scientific intelligence, connected evidence, operational expertise and AI-enabled execution across the development lifecycle," said Michael Brooks, Chief Operating Officer, Syneos Health. "By grounding AI in deep clinical expertise and real-world experience, we help sponsors reduce complexity, make better-informed decisions and ultimately deliver better outcomes for patients." About Syneos Health Syneos Health(R) is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. News Break Middle East translate unique clinical, commercial and real world insights into outcomes to address modern market realities. News Break Middle East bring together a talented team of professionals with a deep understanding of patient and physician behaviors and market dynamics. Together News Break Middle East share diverse insights, use the latest technologies and apply advanced business practices to speed its customers' delivery of important therapies to patients. Syneos Health is powered by an authentic, inclusive and high-performance culture that cares for colleagues, customers, patients, communities and the environment. Press/Media Contact: Meg Byers Director, External Communications [email protected] Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. News Break Middle East do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Syneos Health

Principal Clinical Trial Regulatory Affairs

About the job