Regulatory Operations Specialist

Overview

This role is offered on behalf of a partner company that handles the application process. The Regulatory Operations Specialist position is based in the United States and plays a crucial role in supporting global regulatory submission efforts by coordinating documentation, compliance workflows, and registration projects across various international markets.

Responsibilities

• Coordinate regulatory submission timelines in alignment with international business units, market regulatory teams, distributors, and stakeholders globally.
• Oversee the preparation, assembly, and review of regulatory submission dossiers for new registrations, renewals, and follow-up activities post-submission.
• Collaborate closely with factories, R&D, quality assurance, and regulatory teams to gather necessary documentation ensuring submissions meet specific market standards.
• Conduct comprehensive quality reviews of regulatory documents to confirm accuracy, completeness, and adherence to compliance standards before submission.
• Manage regulatory projects through registration management systems, maintaining submission tracking records, databases of licenses, and requirement spreadsheets.
• Contribute to the creation and standardization of regulatory document templates across different markets and product types.
• Provide training and guidance to stakeholders on regulatory registration systems and procedural requirements.
• Coordinate change management processes including assessments, documentation updates, and communication efforts.
• Support import and export logistics by supplying necessary regulatory documentation.
• Deliver operational assistance for global regulatory teams, including participating in ad hoc projects and process enhancement initiatives.

Requirements

• Bachelor’s degree or higher in Food Science, Pharmaceutical Science, related scientific fields, or equivalent professional experience.
• At least 5 years of experience in regulatory affairs, quality assurance, research and development, or similar roles within food, supplement, or pharmaceutical industries.
• Demonstrated knowledge of regulatory registration procedures, submission documentation, and compliance requirements is preferred.
• Experience in preparing regulatory dossiers and managing market submissions is a significant advantage.
• Proven ability to manage projects and collaborate effectively with cross-functional teams.
• Familiarity with regulatory management systems, document control platforms, or submission tools is beneficial.
• Highly organized with proven ability to juggle multiple priorities and adhere to deadlines.
• Exceptional attention to detail for thorough document review and quality assurance.
• Strong communication skills and capability to manage stakeholder relationships effectively.
• Proficient in English; additional language skills considered a positive.

Benefits

• Salary range between $70,000 and $85,000 per year.
• Incentives tied to individual performance.
• 401(k) retirement plan including company match contributions.
• Comprehensive health insurance coverage.
• Robust total rewards package supporting physical, financial, and emotional wellness.
• Opportunities for professional development and career advancement.
• Flexibility to work remotely.
• Chance to engage with global teams on impactful health and nutrition projects.

Additional Information

This role is offered through a partner company that manages the recruitment process internally after candidate selection. The use of AI tools assists in application review to ensure objective matching to core requirements, but final hiring decisions are human-made. Applicants' personal data will be processed under applicable privacy laws for recruitment purposes, and applicants have rights to manage their data privacy. No external application submissions or links are required beyond the partner's process.