Regulatory Operations Specialist

Job Description

• This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Operations Specialist based in the United States. This role supports global regulatory submission activities by coordinating documentation, compliance processes, and registration projects across multiple markets. The successful candidate will collaborate with regulatory, quality, R&D, manufacturing, and supply chain teams to ensure accurate and timely product registrations. You will play a key role in managing regulatory dossiers, maintaining submission systems, and supporting market access initiatives. This position offers the opportunity to contribute to international projects within a science-driven environment focused on improving health and wellness. You will leverage regulatory expertise, project management skills, and digital tools to streamline processes and maintain compliance standards. Ideal candidates are detail-oriented professionals who enjoy cross-functional collaboration and solving complex regulatory challenges.
• Accountabilities The Regulatory Operations Specialist will coordinate regulatory operations activities, ensuring registration requirements are met and submission documentation is prepared accurately and efficiently. This role requires strong collaboration with global stakeholders and effective management of regulatory systems and processes. Follow regulatory submission plans and coordinate timelines with international business teams, market regulatory teams, distributors, and global stakeholders. Manage the preparation, compilation, and review of regulatory submission dossiers for new registrations, renewals, and post-submission activities. Collaborate with factories, R&D teams, quality teams, and regulatory stakeholders to collect required documentation and ensure submissions meet market requirements. Perform final quality reviews of regulatory documents to ensure accuracy, completeness, and compliance before submission. Manage regulatory projects through registration management systems, maintaining submission records, requirements spreadsheets, and license databases. Support the creation and harmonization of regulatory document templates across markets and product categories. Assist stakeholders with training and guidance on regulatory registration systems and processes. Coordinate management of change controls, including regulatory assessments, documentation updates, and communication activities. Support import and export activities by providing required regulatory documentation. Provide additional operational support to global regulatory teams as needed, including ad hoc projects and process improvements. Requirements The ideal candidate is a regulatory affairs professional with experience in food, supplements, pharmaceuticals, or related industries, combining technical knowledge with strong organizational and project management skills. Bachelor’s degree or higher in Food Science, Pharmaceutical Science, a related scientific discipline, or equivalent experience. Minimum of 5 years of experience in regulatory affairs, quality, R&D, or related functions within the food, supplement, or pharmaceutical industry. Experience with regulatory registration processes, submission requirements, and compliance documentation is preferred. Knowledge of regulatory dossier preparation and market submission processes is a strong advantage. Experience managing projects and collaborating with cross-functional teams. Familiarity with regulatory systems, document management platforms, or registration tools is preferred. Strong organizational skills with the ability to manage multiple priorities and meet deadlines. Excellent attention to detail and ability to perform accurate document reviews. Strong communication and stakeholder management skills. Fluent English communication skills; additional languages are considered a plus. Benefits Competitive salary range of $70,000 - $85,000 annually. Performance-based incentives. 401(k) plan with company match. Comprehensive healthcare coverage. Competitive total rewards package. Additional benefits supporting physical, financial, and emotional wellbeing. Opportunities for professional growth and career development. Remote work flexibility. Opportunity to collaborate with global teams on impactful health and nutrition initiatives.
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