Role Overview We are seeking a Regulatory Affairs Specialist - Nutraceuticals/Food Supplements to lead global regulatory strategy and execution for multi-market product registration projects. This role serves as the primary regulatory expert for client engagements, driving regulatory submissions, coordinating with regional regulatory teams, and ensuring compliance across global markets. In addition to client delivery, the role will support operational excellence initiatives including SOP development, regulatory intelligence management, and identification of technology solutions to improve regulatory workflows.

Key Responsibilities: Regulatory Strategy & Client Leadership - Serve as the regulatory subject matter expert and technical lead on multi-market product registration projects.

• Develop regulatory strategies aligned with product portfolios, target markets, and commercialization timelines.
• Prepare, review, and manage regulatory submissions and dossiers across global markets (e.g., FDA, EU, Health Canada, GCC, APAC).
• Provide regulatory guidance to cross-functional teams including R&D, marketing, and supply chain.
• Manage project timelines, deliverables, and stakeholder communication.

Global Regulatory

Coordination - Coordinate with regional regulatory teams and external consultants to ensure accurate and timely submissions.

• Ensure regulatory consistency and quality across multi-jurisdictional projects.
• Support interactions with regulatory agencies, notified bodies, and local market partners.
• Identify appropriate regional regulatory expertise for specific markets. Compliance & Lifecycle Management - Advise on post-market compliance including labeling updates, product changes, claim reviews, and renewals.
• Review product labels, marketing claims, and technical documentation for regulatory compliance.
• Monitor global regulatory updates and assess their impact on product registrations and market access.

Operational

Excellence - Develop and implement SOPs for regulatory activities including market assessment, submission preparation, and compliance monitoring.

• Maintain a centralized regulatory intelligence repository including market requirements, templates, and guidance documents.
• Establish quality control and peer review processes for regulatory deliverables.
• Support proposal development by providing technical inputs and project scoping.

Regulatory

Technology & Process Improvement - Identify opportunities to leverage regulatory technology and automation to improve efficiency.

• Evaluate tools for regulatory information management, submission tracking, and data management.
• Advise on digital solutions to enhance regulatory compliance processes and monitoring.

Qualifications Required

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Food Science, Biochemistry, or related field.
• 8+ years of regulatory affairs experience in dietary supplements, nutraceuticals, probiotics, or functional foods.
• Experience managing regulatory submissions across multiple global markets (e.g., US, EU, Canada, GCC, APAC).
• Strong knowledge of DSHEA, 21 CFR Parts 101 & 111, EU Novel Food regulations, and international regulatory frameworks.
• Experience working with regulatory consulting firms, CROs, or product/ingredient companies.
• Strong project management and stakeholder communication skills.