The Role & Your ImpactAs a Senior Regulatory Specialist, you will operate as an individual contributor under limited direction, focusing on dossier writing and delivering high-quality regulatory documentation across North America (U.S. and Canada). This is primarily an execution and optimization role, with opportunities to improve processes and digital workflows.
Key responsibilities include:
- Lead and execute dossier writing as your primary focus, including preparation of regulatory dossiers, notifications, submissions, and compliance documentation
- Provide practical, timely regulatory guidance on product and ingredient status, labeling/claims, specifications, and manufacturing considerations
- Support product launches, innovation, and change management through regulatory assessments and deliverable tracking
- Monitor and interpret regulatory developments in North America, translating them into business impact and recommended actions
- Support interactions with regulatory authorities, customers, suppliers, and industry associations
- Enhance digital ways of working by improving tracking systems, reporting, dashboards, and documentation practices
- Contribute to procurement-related regulatory activities and documentation requirements
What You'll Need to Be Successful- Bachelor's degree in Food Science, Food Engineering, Chemistry, Biology, Nutrition, Pharmacy, or a related natural science field
- 4-6+ years of experience in Regulatory Affairs within food or a regulated industry
- Strong hands-on experience with dossier writing and U.S./Canada regulatory submissions
- Expertise in regulatory documentation, labeling/claims, and ingredient compliance
- Strong written communication skills, particularly for regulatory documentation
- Proficiency in Microsoft Office and comfort with digital tools, tracking systems, and reporting
- Fluency in English with advanced professional writing skills
Key competencies:
- Strong ownership and ability to work independently while managing priorities
- Exceptional attention to detail and ability to produce audit-ready documentation
- Ability to translate complex regulations into practical business guidance
- Strong decision-making and prioritization skills
- Collaborative mindset with the ability to influence without authority
Additional Skills & Interests We Value- Experience with enzymes, cultures, probiotics, or food ingredients
- Background supporting Food & Beverage innovation or product launches
- Experience working in global, cross-functional environments
- Exposure to regulatory authorities such as FDA, Health Canada, or CFIA
- Interest in process improvement, digitalization, and workflow optimization
What We OfferAt Novonesis, we offer the opportunity to make a meaningful impact in a purpose-driven organization where science and innovation drive sustainable solutions.
You will benefit from:
- A collaborative and inclusive work environment
- Opportunities to work cross-functionally and globally
- Continuous learning and development opportunities
- A culture that encourages innovation, ownership, and growth
- The chance to contribute to digital transformation and process improvement initiatives
Ways of WorkingThis role follows a hybrid working model, with regular collaboration across North America Regulatory Affairs and global stakeholder groups.
- Hybrid setup with flexibility in working arrangements
- Travel required: approximately 20-30% (including stakeholder meetings, customer interactions, and team engagement)
Application deadline: 7/31/26
- Location: Franklinton, NC (Hybrid)
- Estimated salary range: $105,000-$110,000 based on experience
Benefits you will enjoy:- 401(k) with up to a 9% company contribution
- Minimum of 3 weeks of vacation plus 12 holidays and 2 weeks of Wellness Time
- Health, Dental, Vision & Life insurance
- Healthcare savings account option
- Employee assistance program
- Parental leave
- Tuition reimbursement
- All benefits begin on your first day
