Job Overview
Location
6 Locations
Job Type
Full-time
Category
Product Management
Date Posted
June 23, 2026
Full Job Description
đź“‹ Description
- • Oversees the delivery and performance of global regulatory affairs activities, including leadership of Regulatory Affairs Managers and Regulatory Affairs Specialists.
- • Provides expert regulatory advice and contributes to regulatory project work for internal and external stakeholders.
- • Drives overall planning and oversight for regulatory affairs activities to ensure high-quality, timely delivery aligned with project deliverables.
- • Leads regulatory affairs-related business development activities, including participation in Proposal Strategy Meetings, preparation of regulatory sections for proposals and feasibility reports, regulatory costing, budgeting, contracting, and essential document management.
- • Maintains current expertise in evolving regulatory requirements and ensures the regulatory affairs team is proactively trained on local and international regulations.
- • Ensures compliance with SOPs, ICH GCP, and all applicable regulatory and quality standards across the regulatory affairs group.
- • Fosters professional relationships with internal and external contacts at local and international levels to expedite regulatory dossier submissions and approvals.
- • Prepares technical and master study documentation in accordance with study requirements, contracted scope, and applicable legislation.
- • Accountable for the performance and development of direct reports to ensure critical path activities are completed on time and regulatory affairs activities are optimally initiated and conducted.
- • Identifies and mitigates risks in project deliverables by implementing preventive measures and contingency plans, and presents these strategies to sponsors.
- • Manages team workload, including resource allocation, holiday approvals, and backup planning to maintain operational continuity.
- • Builds, develops, coaches, and leads a global team responsible for regulatory affairs activities.
- • Represents the regulatory affairs function in customer-facing meetings including Governance, bid defense, and escalation discussions.
- • Participates in the development and maintenance of departmental processes, tools, policies, SOPs, and associated documentation.
- • Supports Site Activation leadership and other departments by leading or participating in cross-functional initiatives, task forces, and training programs.
- • Applies strong oral and written communication skills to interpret and present complex regulatory information clearly and concisely.
- • Demonstrates proven leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquing regulatory operations.
- • Proficient in MS-Office applications (Word, Excel, PowerPoint), regulatory portals, and internal Worldwide systems.
- • Maintains expert understanding of clinical research principles and processes.
- • Independently manages multiple high-priority tasks in a fast-paced, evolving environment with self-motivation, organization, and methodical problem-solving.
- • Exhibits excellent interpersonal skills in a deadline-driven, dynamic workplace.
🎯 Requirements
- • Minimum four-year college degree with major concentration in medical, biological, physical, health, pharmacy, or related science OR two-year college curriculum/equivalent education/training (e.g., nursing or life science degree) with eight years’ clinical research experience (e.g., CRA, Reg Affairs)
- • Minimum 10 years of experience within the pharmaceutical or CRO industry with demonstrated senior-level regulatory or clinical start-up experience
- • Proficient in cross-cultural communication and fluent in both spoken and written English
- • Expert understanding of clinical research principles, ICH GCP, and regulatory quality regulations
- • Proven leadership experience managing teams of regulatory affairs professionals globally
- • Proficiency in MS-Office applications, regulatory portals, and company-specific systems
🏖️ Benefits
- • Opportunity to work with a global team of over 3,500 experts committed to improving patient lives
- • Collaborative and supportive team environment that prioritizes diversity, inclusion, and employee well-being
- • Remote work flexibility with presence across six global locations
- • Exposure to high-impact projects in clinical research and regulatory strategy at a pioneering CRO
- • Professional development through training and leadership growth opportunities
- • Equal opportunity employer offering fair and inclusive employment practices
Skills & Technologies
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About Worldwide Holdings Corporation
Worldwide Holdings Corporation is a diversified global enterprise engaged in the development, manufacturing, and marketing of a wide range of products and services. The company operates across various sectors, including technology, consumer goods, and industrial solutions, with a strong focus on innovation and sustainability. Worldwide Holdings Corporation is committed to delivering high-quality products and exceptional customer service, aiming to foster long-term relationships with its clients and stakeholders. The company's strategic vision involves expanding its global reach, investing in research and development, and adapting to evolving market demands to maintain a competitive edge in the international marketplace. Their mission is to create value through responsible business practices and a dedication to excellence.
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