Job Title:
Regulatory Operations Assistant II
Company:
Fortrea
🌐 www.fortrea.com
Job Details:
Job ID: 254598
Category: Clinical
Locations: Available in 2 locations
Work Environment: Office or remote
Job Overview:
Responsible for the creation, revision, compilation, and approval of regulatory specifications and documents for submissions to health authorities across US, EU, Japan, and Rest of the World (ROW). Provide oversight and coordination with cross-functional teams to support product registrations and lifecycle maintenance.
Key Responsibilities:
📄 Regulatory Document Management
Prepare, compile, review, create, revise, and approve product quality (CMC) and other regulatory documents for product development, registration, and post-approval lifecycle maintenance.
Create/revise/approve raw material and packaging specifications and related documentation.
🔄 Change Control & Coordination
Coordinate with cross-functional teams to evaluate and assess the impact of change controls.
Review implementation strategies and required documentation related to change control.
Manage Out of Specification (OOS), Out of Trend (OOT), or other product-related changes, as needed.
💼 Operational Support
Support financial data management, business plan file creation and maintenance, supplier data management, and purchase order creation.
Assist in creation and update of global labeling documents, QC, and related activities.
Support stability data evaluation, report preparation, and dissolution profile evaluation.
Conduct literature surveys and prepare regulatory documents for excipients, APIs, and drug products.
Coordinate import license requirements, investigation report drafting, and document management with internal and external stakeholders.
⚙️ Quality & Systems Support
Set and justify specifications, ensure quality levels for laboratory support.
Perform Computerized System Validation (CSV) and upgrades of systems/software as applicable.
Maintain up-to-date knowledge of regulatory guidelines and apply consistent, efficient, quality processes.
Track metrics, perform quality checks, document results, and highlight trends.
📚 Training & Mentorship
Maintain training documentation as per Fortrea and client requirements.
Support onboarding, training, and mentoring of new associates.
🚩 Issue Escalation & Communication
Escalate unresolved issues timely to internal and external client contacts.
Other duties as assigned by management.
Minimum Qualifications:
🎓 Education:
Bachelor’s degree in Pharmacy or related science (or equivalent).
Advanced degrees (Masters/PhD) considered as applicable.
Fortrea may consider relevant experience in lieu of formal education.
🗣️ Language Skills:
Proficient in English and/or other applicable languages.
Experience:
1-2 years in Regulatory Affairs, Quality Assurance, Analytical Science, Pharmaceutics, material management, or overall drug development and manufacturing processes.
Familiarity with pharmaceutical product lifecycle, regulatory requirements, GxP, and ICH-GCP guidelines preferred.
Technical proficiency with Microsoft Office and document management/publishing tools.
Preferred Qualifications:
Diploma or certification in Regulatory Affairs.
Experience with Management Information Systems (MIS) and electronic data management systems (e.g., Regulatory Information Management).
Strong interpersonal, organizational, analytical, and customer service skills.
Proactive, goal-oriented with good review skills and quality focus.
Physical Demands / Work Environment:
No special physical demands.
Office or remote work environment.
Equal Opportunity Employer:
Fortrea is committed to providing equal employment opportunities and fostering an inclusive workplace for all employees.
🔗 Learn more about EEO & Accommodations
About Fortrea:
Fortrea is a global contract research organization (CRO) providing clinical development and technology solutions across 20+ therapeutic areas in nearly 100 countries. We are dedicated to accelerating life-changing therapies for patients worldwide.
Our Culture – Fortrea FOUR:
Forward Together
Own It
Uphold Integrity
Respect People
Join us to make a meaningful global impact in clinical research.
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