
Regulatory Affairs Manager, Asia
2 days ago
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 regul
-
Regulatory Affairs Manager, Asia
2 weeks ago
Singapore GC ASIA DENTAL PTE LTD Full time6 months contract(Convertible to Perm) **Responsibilities: - Responsible for regulatory activities in SE Asia: regulatory submissions, compliance for new or existing products - Manage registration plans for new products, variations, modifications, registration renewals - Analyse registration complexity and provide regulatory advice to internal and GC groups...
-
Regional Regulatory Affairs Lead – Asia
4 weeks ago
Singapore Charterhouse Pte Ltd Full timeCoverage: Asia Region Industry: Biologics / Specialty Pharmaceuticals Our client is a leading multinational company in the biologics sector, committed to improving patients' lives through high-quality, innovative therapies. With a strong global footprint and a pipeline of specialty products, they are now seeking a Regional Regulatory Affairs Lead to join...
-
Regional Regulatory Affairs Lead – Asia
1 week ago
Singapore Charterhouse Pte Ltd Full timeCoverage: Asia RegionIndustry: Biologics / Specialty PharmaceuticalsOur client is a leading multinational company in the biologics sector, committed to improving patients' lives through high-quality, innovative therapies. With a strong global footprint and a pipeline of specialty products, they are now seeking a Regional Regulatory Affairs Lead to join their...
-
Regulatory Affairs Manager, Rest of Asia
2 weeks ago
Singapore Shell Full time**The Role**: **Where you fit in** Shell Energy Ambitions envisage trading a full range of gas/LNG and clean power products in new countries and being a leader in the provision of cleaner energy. Understanding the complex regulatory environment for gas and gas decarbonization, translating regulations into winning and defensive commercial structures,...
-
Associate, Regulatory Affairs
2 weeks ago
Singapore ASIA PACIFIC MEDICAL TECHNOLOGY ASSOCIATION LTD. Full time**About APACMed** Founded in 2014, the Asia Pacific Medical Technology Association (APACMed) is the first and only regional MedTech association in APAC, representing medical technology manufacturers (multinational corporations as well as small and medium enterprises), and local industry associations across the region. We are fully committed to facilitating...
-
Regulatory Affairs Manager, Asia
4 days ago
Singapore Glanbia Performance Nutrition Full timeGlanbia 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...
-
Regulatory Affairs Intern
1 week ago
Singapore Food Industry Asia (FIA) Full time**REGULATORY AND PUBLIC AFFAIRS INTERN **What to expect**: The **Regulatory and Public Affairs Intern **will provide support to the organisation and its Committees. Reporting to Leadership Team, this role will support the team to achieve FIA’s ambition of being the leading organisation in navigating and shaping the food policy and regulatory developments...
-
Regulatory Affairs
3 weeks ago
Singapore SCIMED (ASIA) PTE LTD Full timeRoles & ResponsibilitiesPrincipal Task: The successful candidate will first and foremost be responsible for regulatory affairs and product registrations for all SciMed products. The candidate will be the focal point of contact for advice on regulatory guidelines and activities. Besides regulatory affairs, the candidate will also support the Management...
-
Regional Regulatory Affairs Manager
2 days ago
Singapore TMS Talent Full time**Location**: Singapore Job highlights The opportunity to make a real impact. Immediately Interview Work in a fast-paced and exciting environment Our client's innovations are transforming healthcare. They need an experienced Senior Regulatory Affairs. You will lead Southeast Asia regulatory initiatives to ensure their varied pharmaceuticals and medical...
-
Senior Director, Head of Regulatory Affairs, Asia
13 hours ago
Singapore BeiGene Full time**Job Description**: About the Company: - BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SHA: 688235) is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 9,500 employees across the United States, China, Europe and Asia Pacific region, BeiGene is advancing...