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Jti Co. Ltd. - Raleigh, NC
posted 2 months ago
About the position
The Regulatory Science Product Characterization Manager at JTI will play a crucial role in supporting the delivery of product characterization and stability assessments as part of the company's Regulatory Science Strategy. Reporting to the VP of Regulatory Science, the incumbent will collaborate closely with the Regulatory Science Nonclinical Director and Manager, ensuring that all externally conducted studies adhere to defined protocols and quality standards. This position involves managing data quality control, providing scientific input, and contributing to regulatory submissions, while also engaging with cross-functional teams to communicate strategic priorities and updates.
Responsibilities
- Work closely with the Nonclinical Director and Manager to steer nonclinical initiatives.
- Maintain close links with assigned contract research organizations, managing contract execution and protocol adherence across the portfolio of Regulatory Science studies.
- Serve as study monitor, managing data quality control, interpretation, writing, and issuance of final reports.
- Ensure data integrity and resolution of quality issues in compliance with guidelines and standard operating procedures.
- Manage the integration of product characterization best practices across all Regulatory Science nonclinical initiatives.
- Perform quality control reviews of all data and reports provided by external vendors.
- Support the annual Regulatory Science planning process by collating information for nonclinical operations activities.
- Contribute to the assessment and internal reporting of product characterization and regulatory industry trends.
- Communicate Regulatory Science strategic priorities and deliverables to internal business functions.
- Prepare materials for publication and presentations, both internal and external.
Requirements
- Degree (Masters or PhD preferred, or BS with relevant experience) in biology, toxicology, analytical chemistry or similar disciplines.
- 3+ years of experience in a multinational organization in a highly regulated industry (Tobacco, Pharma, medical devices).
- Experience conducting, managing, and performing quality control on product characterization/nonclinical studies.
- Practical knowledge of product characterization aspects including assessment of extractables, leachables, and stability.
- Working knowledge of analytical technologies such as GC-MS, LC-MS, and ICP-MS is desirable.
- Experience with the US FDA regulatory environment and regulatory submissions is desirable.
- Strong organizational and communication skills, with the ability to analyze and convey information clearly.
- High attention to detail and ability to review large amounts of material efficiently.
Nice-to-haves
- Relevant certification(s) in the field of regulatory science or product characterization.
- Experience in cross-functional team collaboration.
Benefits
- Annual Performance-based Bonus
- Employee Stock Purchase Plan
- Personal Development
- Medical, Dental & Vision Plan for employees & family members
- Life insurance
- Matching 401(K)
- Paid Time Off (PTO)
- Paid Family Leave of 20 Weeks
- Short-Term & Long-Term Disability
- Education Tuition Assistance
- Flexible Dress Code
- Hybrid Work Setup
- Snacks & Drinks
- Office Parties
- Volunteering Activities
- Employee Assistance Program - counseling for employees & family members.
