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Worldwide Clinical Trials

Contract research organization delivering clinical trials

Regulatory Specialist

Full-Time
No salary listed
Mid
Bachelor's
Seoul, South Korea
Remote
Biology & BiotechClinical Research Operations, Regulatory & Quality (Life Sciences)

About the job

Requirements
  • Organizational and time management skills.
  • Aptitude for planning, strategizing, managing, monitoring, scheduling, and critiquing.
  • Strong written and verbal communication skills to present information clearly and concisely in English and the local language.
  • Ability to handle multiple tasks in a fast-paced and changing environment.
  • Proficiency in Microsoft Word, Excel, and PowerPoint.
  • Strong understanding of country-level cultural norms and local healthcare systems, with ability to initiate and develop relationships with local investigators and key site personnel.
  • A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related sciences.
  • Minimum three years of experience in clinical research, preferably in site activation and/or regulatory-related functions.
  • Previous experience within the pharmaceutical or CRO industry.
  • Thorough knowledge of ICH GCP, the EU Clinical Trials Directive, and other relevant guidance on conducting clinical research.
  • Experience in regulatory submissions in South Korea.
Responsibilities
  • Liaise with SAR colleagues to drive the planning, organization, compilation, progress tracking, and timely submission of regulatory submissions with a consistently high level of quality.
  • May act as a contact point for translation review of submission documents such as applications, synopses, informed consent forms, and labels.
  • Maintain country-specific patient information sheet and consent form customization text, drug labeling information, and Country Intelligence Pages.
  • Review relevant documentation, including labels, patient information sheets, and diary cards, and make recommendations to ensure compliance with ICH GCP and country-specific requirements.
Desired Qualifications
  • Multilingualism is preferred.
  • Working knowledge of English.

About the company

W

Worldwide Clinical Trials

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Worldwide Clinical Trials is a contract research organization that provides drug development services for pharmaceutical and biotech companies, focusing on running clinical trials to bring new medicines to market. Its core work centers on the science and logistics of clinical trials—designing studies, coordinating sites and investigators, and managing data and regulatory processes to advance drug candidates through development. The company differentiates itself through its specialized, science-driven approach and global expansion achieved via strategic acquisitions, building a larger network and broader capabilities to support complex trial programs. After a history of ownership changes, including a re-launch in 2007 and a majority stake sale in 2023, the firm aims to grow further under new ownership while continuing to offer focused clinical trial services that support medical advancement.

Company Size

1,001-5,000

Company Stage

Acquired

Total Funding

N/A

Headquarters

Morrisville, North Carolina

Founded

1986

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Simplify Jobs

Simplify's Take

What believers are saying

  • Catalyst closed by August 31, 2026, lifting employee count to about 4,400.
  • Medidata Plus expands AI workflow reach across study design, data, and patient experience.
  • Every Cure partnership and rare-disease events strengthen sponsor access and scientific credibility.

What critics are saying

  • Fortrea's September 2, 2026 deal strips out Worldwide's Austin and San Antonio early-phase engine.
  • Revelio shows 2026 headcount fell 1.5%, while job postings dropped 89.9% from 2025.
  • Catalyst integration through 2026 risks distraction, attrition, and duplicated oncology leadership layers.

What makes Worldwide Clinical Trials unique

  • Catalyst added oncology and FSP depth on January 20, 2026.
  • Worldwide became Medidata's first CRO to implement Medidata Plus on April 23, 2026.
  • Worldwide spans 70+ countries with neuroscience, oncology, rare disease, and internal medicine focus.

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Benefits

  • Remote Work Options

Growth & Insights and Company News

Headcount

6 month growth

5%

1 year growth

5%

2 year growth

5%
Asianet-Pakistan (Pvt.) Ltd.
Oct 17th, 2026
Fortrea completes acquisition of the Early Phase Services division from Worldwide Clinical Trials.

Fortrea completes acquisition of the Early Phase Services division from Worldwide Clinical Trials. Expands Fortrea's early clinical development network with dedicated bioanalytical capabilities, increased clinical research unit capacity and a more integrated platform for clients. Highlights * Fortrea completes acquisition of the Early Phase Services division from Worldwide Clinical Trials * Adds a 60,000-square-foot GLP-compliant bioanalytical laboratory in Austin, Texas; a 200-bed GCP-compliant clinical pharmacology unit in San Antonio, Texas; and a biospecimen storage facility in Pflugerville, Texas * Expands Fortrea's early clinical development capacity to more than 570 beds globally and adds dedicated large and small molecule bioanalytical capabilities * Enables more integrated execution of early-phase studies by reducing operational handoffs between clinical and bioanalytical functions * Strengthens Fortrea's end-to-end clinical development platform supporting clients from first-in-human studies through Phase IV and post-approval evidence generation * Supports Fortrea's growth strategy by scaling early clinical development capabilities, increasing clinical research unit capacity and enhancing the company's ability to create long-term value for shareholders * Provides continuity of operations, study delivery and client support throughout the transition through a strategic alliance agreement between the companies DURHAM, N.C., Oct. 19, 2026 (GLOBE NEWSWIRE) - Fortrea (Nasdaq: FTRE) (the "Company"), a leading global contract research organization ("CRO"), today announced it has completed its acquisition of the Early Phase Services division from Worldwide Clinical Trials. The division consists of a Clinical Research Unit ("CRU") and Bioanalytical Laboratory operations, in an all-cash transaction valued at approximately $45 million. The acquisition strengthens Fortrea's end-to-end clinical development platform by adding a 200-bed Good Clinical Practice-compliant CRU in San Antonio, Texas; a 60,000-square-foot Good Laboratory Practice-compliant bioanalytical laboratory in Austin, Texas; and a biospecimen storage facility in Pflugerville, Texas. Together, these assets expand Fortrea's early-phase capacity to more than 570 beds globally and add in-house large and small molecule bioanalytical capabilities to support clients from first-in-human studies through proof-of-concept and later-stage development. "Completing this acquisition further strengthens our integrated, scalable and scientifically differentiated clinical development platform," said Anshul Thakral, CEO of Fortrea. "This transaction demonstrates tangible progress in Fortrea's return to growth as we invest in our ability to win new opportunities and create lasting value for clients. By bringing together complementary clinical pharmacology and bioanalytical capabilities, we expect to expand the speed, flexibility and talent we can offer clients as they advance increasingly complex development programs. We are pleased to welcome the Early Phase Services team to Fortrea and look forward to delivering a seamless experience for clients, volunteers and the patients we ultimately serve." "With this investment, Fortrea adds capability and capacity in its commitment to help clients design and execute early development programs with greater speed, scientific rigor and operational connectivity," said Scott Dove, Ph.D., president, Clinical Pharmacology Services at Fortrea. "The addition of dedicated bioanalytical capabilities and expanded CRU capacity gives our teams more ways to support both simple and complex studies, streamline execution and generate high-quality data that inform development decisions." The addition of these capabilities complements Fortrea's existing Clinical Pharmacology Services business and broadens its North American CRU footprint. The combined platform is designed to reduce operational handoffs between clinical and bioanalytical functions, improve turnaround times and provide clients with greater flexibility for complex and larger participant studies, broader access to distinct volunteer populations and expanded bedspace capacity across Fortrea's early development network. Fortrea and Worldwide Clinical Trials have also entered into agreements intended to support continuity for clients, employees and ongoing programs. Both organizations remain focused on maintaining project momentum and providing a seamless transition for employees, clients and volunteers. The acquired Early Phase Services operations are now part of Fortrea's Clinical Pharmacology Services business unit. Advisors Barclays served as financial advisor to Fortrea, and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. served as its legal counsel. About Fortrea Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development solutions to the life sciences industry. Asianet Pakistan partner with emerging and large biopharmaceutical, biotechnology, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients. Fortrea provides phase I-IV clinical trial management, clinical pharmacology and consulting services. Fortrea's solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Its talented and diverse team working in about 100 countries is scaled to deliver focused and agile solutions to clients globally. Learn more about how Fortrea is streamlining drug development at Fortrea.com and follow Asianet Pakistan on LinkedIn, X and Bluesky. Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the federal securities laws, including Section 27A of the Securities Act and Section 21E of the Exchange Act. Forward-looking statements by their nature address matters that are, to different degrees, uncertain, such as statements about the anticipated benefits of the transaction, including future financial and operating performance, and the anticipated timing for completing the transaction. In this context, forward-looking statements often address expected future business and financial performance and financial condition, and often contain words such as "guidance," "expect," "assume," "anticipate," "intend," "plan," "forecast," "believe," "seek," "see," "will," "would," "target," similar expressions, and variations or negatives of these words that are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results could differ materially from these forward looking statements due to a number of factors, including, but not limited to: the parties' ability to meet expectations regarding the accounting and tax treatments of the proposed transaction; the anticipated benefits of the acquisition may not be realized, or may be realized more slowly or to a lesser extent than expected, difficulties, delays, costs or disruptions associated with integrating the acquired business, operations, employees, systems and processes into the Company, the ability to retain existing customers and business relationships of the acquired operations and win new business following the acquisition, the ability to retain and integrate key employees of the acquired business, the parties' ability to perform their respective obligations under transition services and other agreements, unanticipated liabilities, expenses or adverse effects associated with the acquired business, the ability to maintain applicable regulatory, quality and accreditation requirements for the acquired sites, and other factors described from time to time in documents that the Company files with the SEC. For a further discussion of the risks relating to the Company's business, see the "Risk Factors" Section of the Company's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (the "SEC"), as such factors may be amended or updated from time to time in the Company's subsequent periodic and other filings with the SEC, which are accessible on the SEC's website at www.sec.gov. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included or incorporated by reference in this report and in the Company's filings with the SEC. All forward-looking statements are made only as of the date of this report and the Company does not undertake any obligation, other than as may be required by law, to update or revise any forward-looking statements to reflect future events or developments. Fortrea Contacts Galen Wilson (Media) - 703-298-0802, [email protected] Kate Dillon (Media) - 646-818-9115, [email protected] Tracy Krumme (Investors) - 984-385-6707, [email protected] GlobeNewswire Distribution ID 9848525 October 17, 2026 Islamabad:Most parts of the country are expected to experience dry weather over the next twelve hours. According to Radio Pakistan, the northern areas may see partly cloudy skies, with cold conditions anticipated during the morning and night. October 17, 2026 October 16, 2026

Clinical Trial Vanguard
Sep 3rd, 2026
Fortrea’s $45M Early-Phase Acquisition Will Reshape Your Phase I Startup Timeline, Are You Ready?

Fortrea's $45M acquisition of Worldwide Clinical Trials' early-phase division adds a 60,000 sq ft bioanalytical lab. Here's what it means for Phase I site…

GlobeNewswire
Sep 3rd, 2026
Fortrea acquires the clinical pharmacology unit and bioanalytical laboratory activities of Worldwide Clinical Trials.

Fortrea acquires the clinical pharmacology unit and bioanalytical laboratory activities of Worldwide Clinical Trials. This acquisition brings dedicated bioanalytical expertise and increased capacity to Fortrea's early clinical development network as Worldwide continues its strategy to strengthen its clinical development activities, therapeutic leadership, and presence in high-growth markets.

Australian Associated Press
Sep 2nd, 2026
Fortrea to acquire clinical pharmacology unit and bioanalytical laboratory operations from Worldwide Clinical Trials.

Fortrea to acquire clinical pharmacology unit and bioanalytical laboratory operations from Worldwide Clinical Trials. September 02, 2026 Adds dedicated bioanalytical capabilities and expanded capacity to Fortrea's early clinical development network as Worldwide advances its strategy to scale clinical development, therapeutic leadership and high-growth markets Highlights * Fortrea enters into a definitive agreement to acquire the Early Phase Services division of Worldwide Clinical Trials * Includes a 60,000 sq. ft. GLP bioanalytical lab in Austin; a 200-bed GCP-compliant clinical pharmacology unit in San Antonio; and a biospecimen storage facility in Pflugerville, Texas * Enables integrated execution of early-phase studies with large and small molecule bioanalytical capabilities, enhancing Fortrea's ability to deliver faster, more integrated early clinical development solutions for simple and complex clinical studies * Strengthens Fortrea's end-to-end clinical development platform, supporting customers from first-in-human studies through Phase IV and post-approval evidence generation * Supports Fortrea's growth strategy through expanded scientific capabilities, increased early clinical development capacity and enhanced ability to create long-term value for shareholders * Supports Worldwide Clinical Trials' existing rapid global growth across oncology, neuroscience, internal medicine, and rare disease

Citybiz
Jun 11th, 2026
WCG names Anthony Doyle chief financial officer to support growth.

WCG names Anthony Doyle chief financial officer to support growth. June 11, 2026 Anthony Doyle WCG has appointed Anthony Doyle as chief financial officer, effective June 15, 2026, adding a healthcare and clinical research finance executive as the company continues to expand its role in supporting clinical trial operations and decision-making. Doyle succeeds Robert VanHees, who will remain with WCG as a special advisor through Dec. 31, 2026, to support the transition. The leadership change comes as WCG seeks to strengthen financial operations, capital planning and organizational scale across its global clinical research platform. Doyle brings more than 20 years of financial leadership experience across healthcare, clinical research and both public and private equity-backed companies. He joins WCG from Flourish Research, a clinical trial site network, where he serves as chief financial officer. "Anthony brings a strong combination of financial rigor, operational leadership, and industry experience that aligns with WCG's strategic direction," said Sam Srivastava, chief executive officer of WCG. "He has a proven ability to scale finance organizations, lead complex capital strategies, and support high-growth businesses." Before joining Flourish Research, Doyle served as chief financial officer at BioCryst Pharmaceuticals and Worldwide Clinical Trials. In those roles, he led finance functions through periods of business expansion, operational transformation and capital strategy execution. Earlier in his career, he held finance leadership positions at General Electric, where he developed experience in operational finance, financial planning and analysis, and corporate development. His appointment comes as clinical research organizations and service providers face growing demand for technology-enabled solutions that can improve trial efficiency, reduce risk and support faster development timelines. As sponsors and research partners manage increasingly complex studies, companies such as WCG are expanding capabilities that combine regulatory oversight, data intelligence and operational support. WCG describes itself as a provider of clinical research decision infrastructure, helping organizations manage risk and make more confident decisions across the trial lifecycle. The company's work spans therapies at multiple stages of development, with a platform built around oversight, intelligence and data-driven support. Doyle said WCG's position in the clinical research ecosystem and its growth trajectory were key factors in his decision to join the company. "WCG plays a central role in advancing clinical research with a clear mission and a strong foundation for growth," Doyle said. "I'm excited to join the team and help drive disciplined execution, enable strategic investment, and support the company's continued momentum." Srivastava also credited VanHees for helping position the company for its next phase, noting his leadership and partnership over the past four years. The CFO transition reflects WCG's focus on scaling its financial and operational infrastructure as the company continues to serve pharmaceutical, biotechnology and clinical research partners. In a market increasingly shaped by data, artificial intelligence and pressure to improve trial performance, financial leadership is becoming central to how clinical research platforms invest, integrate capabilities and manage growth. With Doyle's appointment, WCG is adding an executive with experience across contract research, drug development and growth-stage healthcare organizations as it continues building its platform for clinical trial oversight and decision support.