Fortrea, a global leader in contract research, is transforming drug and device development with its comprehensive suite of clinical development, patient access, and technology solutions. With operations spanning ~100 countries and expertise in over 20 therapeutic areas, Fortrea serves pharmaceutical, biotechnology, and medical device customers. As a company committed to scientific rigor and innovation, Fortrea’s mission is to accelerate the delivery of life-changing therapies to patients worldwide.
Job Responsibilities
As a Regulatory Operations Assistant II, you will play a crucial role in supporting regulatory processes and documentation for pharmaceutical product development and maintenance. Key responsibilities include:
- Document Preparation and Review: Prepare, compile, and review product quality (CMC) and other regulatory documents to support global product registrations and lifecycle maintenance.
- Specifications Management: Create or revise raw material and packaging specifications and associated documentation.
- Cross-functional Coordination: Collaborate with cross-functional teams for change control evaluations, impact assessments, and implementation strategies. Manage OOS, OOT, and other product-related changes.
- Data Management Support: Assist in financial data management, business plan file creation, supplier data management, and purchase order creation.
- Global Labeling: Support the creation and updating of global labeling documents, QC tasks, and associated activities for labeling projects.
- Stability and Evaluation: Evaluate stability data, prepare reports, and analyze dissolution profiles.
- Literature Surveys: Conduct literature reviews to prepare regulatory documents for excipients, APIs, and drug products.
- Import License Coordination: Support import license requirements, draft investigation reports, and manage records and document coordination with internal and external departments.
- System Validation: Perform Computerized System Validation (CSV) and software upgrades to maintain quality standards.
- Regulatory Knowledge: Stay updated on regulatory guidelines and implement efficient processes to ensure high-quality deliverables.
Qualifications and Skills
To excel in this role, candidates should possess:
Qualifications:
- A Bachelor’s or Master’s degree in a relevant field such as Pharmacy, Chemistry, or Life Sciences.
- Prior experience in regulatory operations, preferably in the pharmaceutical or biotechnology industries.
Skills:
- Strong understanding of regulatory guidelines for pharmaceutical products.
- Excellent organizational and documentation skills.
- Ability to collaborate effectively with cross-functional teams.
- Proficiency in data evaluation and report preparation.
- Knowledge of Computerized System Validation (CSV) processes.
- Strong problem-solving and analytical skills.
- Effective communication skills to interact with stakeholders and ensure compliance.
