Fortrea Hiring For Regulatory Operations

We are a leading global pharmaceutical organization committed to improving lives through innovative healthcare solutions. With a strong focus on research, development, and regulatory compliance, we strive to deliver high-quality products that meet global standards. Our team is dedicated to fostering a culture of excellence, collaboration, and continuous learning.

Job Description

Key Responsibilities:

As a Senior Regulatory Operations Specialist I, you will play a pivotal role in ensuring compliance with global regulatory requirements and supporting the lifecycle management of pharmaceutical products. Your responsibilities will include:

1. Regulatory Documentation & Submissions:
   • Prepare, compile, and review product quality (CMC) and other regulatory documents for global product registrations and post-approval maintenance.
   • Support the creation and update of global labeling documents, ensuring compliance with content and format requirements.
2. Change Control & Compliance:
   • Coordinate with cross-functional teams to evaluate change controls, assess implementation strategies, and manage OOS, OOT, or product-related changes.
   • Update and review packaging-specific documents, ensuring alignment with stakeholder requirements.
3. Supplier & Packaging Management:
   • Manage supplier agreements for new packaging development projects and commercial specification updates.
   • Optimize existing packaging components under the guidance of the Packaging Development Engineer.
4. Data Management & Reporting:
   • Support stability data evaluation, dissolution profile analysis, and preparation of regulatory documents for APIs, excipients, and drug products.
   • Perform literature searches to support regulatory submissions.
5. Licensing & Compliance:
   • Manage the submission and maintenance of Import/Export Licenses, Dual Use NOCs, and Import Certificates.
   • Ensure timely license applications, availability, debiting, and reconciliation.
6. Quality Assurance & Training:
   • Perform quality checks, update internal and external trackers, and ensure compliance with regulatory guidelines.
   • Assist in training and mentoring junior staff to foster a culture of continuous improvement.
7. Strategic Coordination:
   • Escalate potential issues and serve as an analytical strategist across product development and post-approval stages.
   • Implement efficient and quality processes to meet regulatory timelines and deliverables.

Qualifications:

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• 5+ years of experience in regulatory operations, CMC, or pharmaceutical product lifecycle management.
• Strong knowledge of global regulatory guidelines (e.g., FDA, EMA, WHO).
• Proficiency in Computerized System Validation (CSV) and software upgrades.
• Excellent communication, organizational, and problem-solving skills.
• Ability to work collaboratively in a cross-functional team environment.

Why Join Us?

• Hybrid Work Model: Enjoy the flexibility of working remotely and in-office.
• Career Growth: Opportunities for professional development and advancement.
• Impactful Work: Contribute to the development of life-saving pharmaceutical products.
• Inclusive Culture: Be part of a diverse and supportive team.

How to Apply

If you are passionate about regulatory operations and want to make a difference in the pharmaceutical industry, we encourage you to apply!

Application Deadline: March 18, 2025

Application Link