Regulatory Affairs Manager, Asia
Date: 27 Oct 2024
Location: SG
Company: Glanbia
Glanbia Performance Nutrition’s purpose is to inspire people everywhere to achieve their performance goals! We are the world’s leading premium sports nutrition company with Optimum Nutrition, Isopure, SlimFast, BSN, Amazing Grass and Nutramino among the brands in the portfolio today. We have ambitious plans for the future, and as a values-led organisation, we’re focused on driving sustainable business performance the right way.
We are seeking a passionate and innovative 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. You will be responsible for (1)reviewing raw materials, product nutrition profile & formulations against country regulations for compliance; (2) work closely with internal stakeholders from the quality control unit to ensure full compliance; and (3)overseeing and managing all regulatory functions related to health supplements manufacturing and product development. This exciting role offers the opportunity to make a significant impact on the company's growth ambition and success in the SEA & North Asia health supplement industry.
Principal Accountabilities
Product Compliance to Local Regulations:
• 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.
Managing External Regulatory/ Government Bodies/ Customs
• 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.
New Product Introduction Support:
• 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
Continuous Improvement:
• 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
Key Challenges and Success Measures
Customer, Stakeholders and Sourcing Site Regulatory Collaboration:
• 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. You will be given the opportunity to operate outside your core role in order to drive change programs that will sustain profitable growth in a dynamic & rewarding culture for all employees that ultimately delivers improved service for our customers and consumers.
• Responsive to stakeholders
Skills, Know How and Experience
Essential
• Experience of 7-10 years on working with regional / country specific regulatory bodies, customs, regulatory consultants, etc.
• Experience in dealing with markets across the Region from an importation and regulatory compliance standpoint, including Southeast Asia, Taiwan, Japan, and Korea
• Detail-oriented with the ability to manage multiple projects and deadlines effectively.
• Demonstrates a willingness to learn and adapt by readily adapting to the dynamic industry challenges.
• Thrives in a collaborative environment where they can share knowledge and learn from colleagues in response to changing market needs.
• Strong analytical and problem-solving skills, with a proactive and solution-driven approach.
• Ability to work collaboratively in a team environment and communicate effectively with internal and external stakeholders across multiple time zones and cultures.
• Strategic thinker with the capability to adapt to changing regulatory landscapes and business needs.
• Results-driven mindset with a commitment to upholding high ethical and professional standards.
• Strong management skills
• Strong ability to research, analyse, problem solving and project management.
• Good working knowledge of Microsoft Office and Adobe products
Desirable
• Experience within the health supplements industry
• Good knowledge of flavors, additives, GMO, organic, Halal suitability, etc.
• Experience with evaluating and editing promotional materials for food and food supplements.
• Capable of handling additional responsibilities based on business needs outside core geographic region that is relevant to business needs with support from GPN Regulatory Affairs Team.
• Understanding of the dedicated sports lifestyle and a strong passion for building nutritional products that support this sector
Where and how you will work
The opportunity will be based in our office located in Singapore with hybrid working arrangements available through our Smart working model which allows you a greater choice in how you work and live, giving you a better work-life balance.
What we would like to offer you!
The opportunity to develop your career on a global stage, continuous learning through an on-demand learning platform, and a competitive compensation package.
At Glanbia, we celebrate diversity, because we know that our individual strengths make us stronger together. We welcome and encourage interest from a variety of candidates, we will give your application consideration, without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status.At Glanbia, our culture celebrates individuality, knowing that together we are more.
At Glanbia, we celebrate diversity, because we know that our individual strengths make us stronger together. We welcome and encourage interest from a wide variety of candidates, and we will give your application consideration, without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, or disability status.
At Glanbia our culture will celebrate individuality, knowing that together we are more.