17 Sep
|
Jobtailor
|
Dartmouth
17 Sep
Jobtailor
Dartmouth
- Research, interpret, and map regulatory requirements, pathways, evidence needs, application steps, and expected timing for market entry across assigned jurisdictions
- Support preparation, coordination, and review of human-food scientific and regulatory submissions, including Novel Food applications, GRAS assessments, registrations, and international dossiers
- Support animal feed and pet food regulatory activities, including pathway assessments, submissions, registrations, renewals, authority responses, documentation, claims, and label development
- Manage assigned submissions, registrations, notifications, renewals, and pre-market regulatory activities from planning through completion
- Coordinate cross-functional inputs, consultant deliverables, authority questions, response packages, and project timelines
- Communicate directly with regulatory authorities on routine assigned matters and participate in regulatory meetings with functional leadership
- Coordinate regulatory documentation for product registrations, including health or sanitary certificates and compliance attestations, and apply document authentication processes as needed
- Maintain regulatory trackers, databases, submission files, document repositories, and project-status tools
- Provide practical regulatory support to R&D;, Quality, Operations, Commercial, customers, and distributors
- Provide regulatory input on formulations, ingredients, specifications, claims, labels, packaging, manufacturing changes, and product-maintenance activities
- Monitor regulatory developments and communicate potential impacts and required actions
- Contribute to regulatory procedures, templates, workflows, and continuous-improvement activities
- Support product and facility certification programs, including organic, non-GMO, vegan, kosher, halal, and other voluntary certification schemes
Requirements
- Bachelor’s degree in life sciences, health sciences,
food science, nutrition, regulatory affairs, animal science, veterinary science, toxicology, biotechnology, biochemistry, or related discipline
- 5+ years of progressive regulatory affairs or relevant submission-based market access experience
- Experience supporting or managing regulatory dossiers, registrations, approvals, notifications, renewals, or compliance activities
- Ability to research, interpret, map, and apply regulatory requirements across multiple jurisdictions or product categories
- Strong project management, organizational, analytical, and written and verbal communication skills
- Ability to independently manage multiple priorities, demonstrate solid attention to detail, and recognize when escalation is required
- Collaborative, practical, and comfortable working in a fast-paced, cross-functional environment
- Preferred: advanced degree, such as a Master’s or Doctorate, in a relevant scientific or health-related discipline
- Preferred: experience with EU or UK Novel Food applications, U.S. GRAS assessments, Canadian Novel Food submissions, Natural Health Product licence applications, infant formula submissions, animal feed ingredient approvals, or other scientific regulatory submissions
- Preferred: exposure to animal feed or pet food regulatory frameworks in the United States, European Union, Canada, or other major markets
- Preferred: experience with international registrations, market-entry assessments, regulatory certificates, document legalization, or regulatory operations processes
- Preferred: experience coordinating consultants, laboratories, or other regulatory service providers
- Preferred: experience in food ingredients, dietary/food supplements, natural health products, biotechnology, animal nutrition, pet food, or a related industry
- Preferred: experience supporting third-party certification programs, including organic, non-GMO, vegan, halal, kosher, or similar voluntary certification schemes
Core Competencies
Demonstrates expertise in regulatory affairs with a focus on market access, submissions, and compliance across multiple jurisdictions. Proficient in managing regulatory documentation, coordinating cross-functional teams, and providing practical support for product certifications and regulatory submissions.
Highest-signal resume keywords
- Regulatory Affairs Experience
- Market Access Submissions
- Project Management Skills
- Regulatory Dossier Management
- Cross-Functional Collaboration
Hard Skills
- Regulatory Requirements Mapping
- Novel Food Applications
- GRAS Assessments
- Submissions Management
- Compliance Activities
- Regulatory Documentation
- Analytical Skills
- Attention to Detail
- Document Authentication Processes
- Regulatory Tracker Maintenance
Soft Skills
- Organizational Skills
- Written Communication
- Verbal Communication
- Collaboration
- Problem-Solving
Certifications & Qualifications
- Advanced Degree in Life Sciences
- Regulatory Affairs Certification
Industry Keywords
- Animal Feed Regulatory Frameworks
- Food Science
- Health Sciences
- Biotechnology
- Natural Health Products
- Dietary Supplements
- Voluntary Certification Schemes
- International Registrations
- EU Novel Food Applications
- U.S. GRAS Assessments
Tools & Technologies
- Regulatory Databases
- Project-Status Tools
- Document Repositories
📌 Senior Specialist, Global Regulatory Affairs (Dartmouth)
🏢 Jobtailor
📍 Dartmouth