Regulatory Operations Specialist

Accountabilities

• Collapse coordination of regulatory operations activities, ensuring registration requirements are met and submission documentation is prepared accurately and efficiently.
• Collapse collaboration with global stakeholders and effective management of regulatory systems and processes.
• Collapse follow regulatory submission plans and coordinate timelines with international business teams, market regulatory teams, distributors, and global stakeholders.
• Collapse management of the preparation, compilation, and review of regulatory submission dossiers for new registrations, renewals, and post-submission activities.
• Collapse collaboration with factories, R&D teams, quality teams, and regulatory stakeholders to collect required documentation and ensure submissions meet market requirements.
• Collapse performance of final quality reviews of regulatory documents to ensure accuracy, completeness, and compliance before submission.
• Collapse management of regulatory projects through registration management systems, maintaining submission records, requirements spreadsheets, and license databases.
• Collapse support of the creation and harmonization of regulatory document templates across markets and product categories.
• Collapse assistance with stakeholders with training and guidance on regulatory registration systems and processes.
• Collapse coordination of management of change controls, including regulatory assessments, documentation updates, and communication activities.
• Collapse support of import and export activities by providing required regulatory documentation.
• Collapse provision of additional operational support to global regulatory teams as needed, including ad hoc projects and process improvements.

Requirements

• Collapse a regulatory affairs professional with experience in food, supplements, pharmaceuticals, or related industries, combining technical knowledge with strong organizational and project management skills.
• Collapse a minimum of 5 years of experience in regulatory affairs, quality, R&D, or related functions within the food, supplement, or pharmaceutical industry.
• Collapse experience with regulatory registration processes, submission requirements, and compliance documentation is preferred.
• Collapse knowledge of regulatory dossier preparation and market submission processes is a strong advantage.
• Collapse experience managing projects and collaborating with cross-functional teams.
• Collapse familiarity with regulatory systems, document management platforms, or registration tools is preferred.
• Collapse strong organizational skills with the ability to manage multiple priorities and meet deadlines.
• Collapse excellent attention to detail and ability to perform accurate document reviews.
• Collapse strong communication and stakeholder management skills.
• Collapse fluent English communication skills; additional languages are considered a plus.

Benefits

• Collapse competitive salary range of $70,000 - $85,000 annually.
• Collapse performance-based incentives.
• Collapse 401(k) plan with company match.
• Collapse comprehensive healthcare coverage.
• Collapse competitive total rewards package.
• Collapse additional benefits supporting physical, financial, and emotional wellbeing.
• Collapse remote work flexibility.
• Collapse opportunity to collaborate with global teams on impactful health and nutrition initiatives.