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Role Overview

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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.

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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.

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Key Responsibilities:

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Regulatory Strategy & Client Leadership

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- 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 Coordinationn
- 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 Managementn
- 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 Excellencen
- 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 Improvementn
- 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.

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Qualifications Required:

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- 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) .
- Robust 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.

Apply on Kit Job: kitjob.in/job/46arel

📌 Regulatory Affairs Specialist - Nutraceuticals/Food Supplements (Bunghmun)
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📍 Bunghmun