Glanbia Performance Nutrition is seeking a Regulatory Affairs Manager to support product commercialization, for GPN owned and contract brands, for all activities involving regulatory compliance from concept to launch in SEA, South Korea, Japan, and Taiwan.
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
- Participate in the design of new product launches by providing regulatory expertise on product formulation, package design, labeling, and claims development including mandatory nutrition labeling, health claims, nutrient content claims, ingredient declaration and allergen labeling
- 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
- Communicate regulatory information to cross-functional teams and ensure that information is interpreted correctly
- Extend support to customers in case of product clearance/customs as needed
- Active contributor to the regional supply Leadership team as a subject matter expert and a business/ brand builder
- Ensure regulatory priorities are in harmony with GPN business priorities
- Provide accurate, risk-based approach to regulatory queries
- Positively add to the culture of the organization and participate across the broad spectrum of activity the function is responsible for in order to deliver on the total organizational goals
Benefits
- Competitive compensation package
- Continuous learning through an on-demand learning platform
- Hybrid working arrangements
