We are seeking a Regulatory Affairs Manager to support product commercialization for GPN owned and contract brands in SEA, South Korea, Japan, and Taiwan. The role will involve reviewing raw materials, product nutrition profile & formulations against country regulations for compliance, working closely with internal stakeholders, and overseeing all regulatory functions related to health supplements manufacturing and product development.
Requirements
- Lead and manage the regulatory affairs function for health supplements in SEA and North Asia
- Develop and implement regulatory strategies to ensure compliance with all relevant laws, regulations, and guidelines
- Lead and manage the preparation of regulatory submissions, including product registrations, licenses, and approvals for new and existing products
- Provide regulatory guidance for the labeling, formula compliance, advertising and marketing of functional foods, dietary supplements, beverages and sports nutrition products in US and International sales channels
- Conduct regulatory assessments and evaluations of product formulations, labeling, and promotional materials to ensure compliance
- Develop Label Specification Sheet with all labelling information, Nutrition/Supplement Fact Panels, and ingredient /allergen statements in compliance with Asian regulations
- Review raw material and ingredient compositions for regulatory conformity based on industry guidelines / international restrictions and to develop Nutrition Fact/Supplement Fact panels from Formulation sheets
- Manage reformulation and relabeling projects in conjunction with US & International Marketing, R&D and Sales teams
- Create and/or update document standard operating procedures for nutrition databases, labeling and regulatory roles
- Develop and implement procedures for creating, reviewing and approving labels to ensure consistency in labelling in the Asian markets
- Conduct regulatory reviews of current GPN Labels/Websites and recommend changes
- Advise on nutrition & health claims to be used on labels and on marketing material
- Support product notifications as per business needs ensuring supply continuity
- Provide responses to regulatory agencies regarding product information or issues
- Assist with activities such as audits, regulatory agency inspections, or product recalls
- Develop relationships with various regulatory agencies, as required
- Assist with investigations relative to product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary
- Manage and track labeling projects across Asia, including a system to provide access to important documents to external stakeholders
- Assist in creation of responses to regulatory agencies regarding product information or issues
- Securing documentation from various government agencies across the Asian region on an as needed basis
- Create product certificates and product documentation for product notification/registration where necessary
- Involvement in project implementation from regulatory perspective for new product introductions
- Support marketing team on creating new product pipelines
- Supporting the launch of compliant branded products according to project timelines
- Work closely with cross functional teams and local distributors to ensure required documentation and compliance evaluations are in place for successful product registration/notification and launch
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products
- Stay abreast of changes in regulatory requirements and industry trends to proactively advise the company on regulatory matters
- Maintain current knowledge of relevant regulations, including proposed and final rules
Benefits
- Competitive compensation package
- Continuous learning through an on-demand learning platform
- Hybrid working arrangements
- Opportunity to develop career on a global stage
