JOB PURPOSE    

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Responsible for providing support pursuant to nutritional supplement regulation to the global regulatory affairs department. Primary responsibilities include supporting the development, substantiation and maintenance of product claims, performing critical review and evaluation of new and existing ingredient status and acceptability, assisting in the regulatory review of marketing materials, and performing reviews of product labeling to ensure regulatory compliance.


ESSENTIAL DUTIES AND RESPONSIBILITIES     


1. Supports product registration for nutritional supplements for global markets ensuring compliance of formulas and that packaging and claims meet country’s regulations. Considers the ramifications of failure to comply with regulations and troubleshoots issues in order to avoid business disruptions. Oversees the tracking of all legally required filings with regulatory agents in the regions (such as product registration certificate, product information file, etc.).  Acts as a liaison with MKI Legal on nutrition. 40 %

2. Remains abreast of all applicable nutritional laws and regulations and utilizes this knowledge to provide optimum benefits to Mark Kay Inc. Assesses new and revised global regulations for changes, challenges and determines impact on the business, providing timely alerts. Works in coordination with market and Legal team to provide consistent and accurate feedback to Management. 10 %

3. Participates on and facilitates the development and proper functioning of inter-departmental, intra-corporate, and inter-corporate teams. Serves as a consultant to top management in long range Company planning concerning proposed areas of growth and development of the nutritional business. Establishes and monitors systems, policies, and procedures for alignment with regulatory compliance requirements.  Provides regulatory information to maintain consistency in the markets, develops strategy to anticipate future challenges, and proactively resolves issues before they occur. 10 %

4. Acts as leader and active participant for nutritional projects by applying and/or developing highly advanced technologies, scientific principles, theories, and concepts for technical and commercial success. Serves as a technical resource by responding to project and claims issues and providing technical training as required to team. 10 %

5. Supports the Regulatory Affairs’ International Restrictions database by monitoring changes in ingredient restrictions promulgated by global authorities, providing regular updates to the database as appropriate. Assists in the development of computer interfaces, as necessary, to facilitate the seamless flow of information. 10 %

6. Cultivates and maintains working relationships with trade associations, government agents, and professional peers through various avenues in order to remain current on pending legislation, court rulings, and industry plans for compliance.  Works to leverage contacts and influences government agencies and the trade with regard to promoting the Company’s interests. Serves on steering committees, including trade association meetings which impact the interests of the Company. 

10 %

7. Provides necessary information to market leadership to aid in start-up operations in international markets; ensures that applicable U.S. and International regulations are understood, and provides technical materials and information.  Tracks projects that are exclusive to foreign affiliates (non-U.S. projects).  Monitors and ensures the nutritional products manufactured and sold by foreign affiliates are compliant with the regulations. 10 %

In addition to the above, incumbent is expected to meet the required competencies for this position as defined in the competency profile.