We are seeking a Project Manager / Regulatory Scientist to work in a multidisciplinary project environment to plan, supervise and manage projects and to participate in the operational requirements to produce written work products to support regulatory compliance related to food and dietary supplements ingredients. This role manages multiple client projects and actively participates in the development of work products.
Key Responsibilities
· Support the Program Manager, Safety Services, in providing services related to Generally Recognized As Safe (GRAS) and Recent Dietary Ingredient (NDI) notifications.
· Plan and manage project budgets, timelines, deliverables, and client communication, ensuring clear expectations and on-time delivery.
· Contribute to regulatory dossier writing with a high standard of accuracy and clarity.
· Maintain strong organization and documentation practices across multiple concurrent client projects.
· Collaborate with internal team members and third-party partners as needed to support project objectives.
· Communicate with regulators effectively to manage submission lifecycle.
Qualifications
· Bachelor’s degree in a scientific discipline (graduate degree an asset).
· 3–5+ years of regulatory experience in dietary supplements and/or foods; consulting experience preferred.
· Strong working knowledge of FDA regulations (21 CFR) related to new ingredients for use in food, dietary supplements and animal feed/food.
· Strong understanding of formal project management methodologies and reporting.
· Exceptional attention to detail and strong prioritization and follow-up skills.
· Highly organized with the ability to manage multiple projects simultaneously.
· Proficiency with MS Word, Excel, PowerPoint, and related software; EndNote experience a plus.