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Sr Specialist Regulatory Affairs

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Research & Development
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JOB PURPOSE    

Supports the Regulatory Affairs department ensuring Company compliance with local, state, federal, and international regulations associated with manufacturing and marketing products.  Serves as a technical member leading projects, supporting MK subsidiaries, partnering with internal divisions and assessing information to support product launches.  Provides recommendations and improvements for the department.


ESSENTIAL DUTIES AND RESPONSIBILITIES     

1. Supports product registration for global markets ensuring compliance for formulas, packaging and claims meet country’s regulations. Considers the ramifications of failure to comply with US and International regulations and troubleshoots issues in order to avoid business disruptions. 40 %

2. Remains abreast of all applicable laws and regulations and utilizes this knowledge to provide optimum benefits to Mark Kay Inc. Assesses new, updated global regulations for changes, challenges and determines impact on the business, providing timely alerts. Works in coordination with subsidiaries 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 new or projected areas of technological research and advancement. 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 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 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 between ERP, LIMS, Agile systems, and the Regulatory Affairs database. 10 %

6. Informs Government Relations, Legal and International Contract Manufacturing departments of legislation that may impact the cosmetics or direct selling industry, and serves as an information resource in the development of strategies to influence the legislative process.  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. 5 %

7. Oversees the tracking of all legally required filings with regulatory agents in the regions (such as product registration certificate, green dot filing, product information file, etc.).  Acts as a liaison with MKI Legal.   . 5 %

8. Provides necessary information to subsidiary 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 products manufactured and sold by foreign affiliates are consistent with the product information packets and regulations.   5 %

9.  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, that are responsible for developing effective strategies for a variety of innovation projects and makes recommendations which impact the profitability of the Company.  (As needed)

5 %

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

KNOWLEDGE, SKILLS AND ABILITIES    

Education  BA/BS, MS/MA

Experience 5 years of Regulatory experience, including 3 years international and industrial experience or equivalent.  Knowledge of devices a plus.

1. Must exhibit an exceptional degree of ingenuity, creativity, and resourcefulness to apply and/or develop highly advanced technologies, scientific principles, theories, and concepts.

2. Must be able to provide solutions to a wide range of difficult and complex problems that require the regular use of ingenuity and creativity.

3. Excellent oral and written communication skills are required in order to interact with various levels of personnel within and outside the Company.

4. Ability to perform duties under very general direction and independently perform assignments with only general criteria for expected results. 

5. Erroneous decisions or recommendations or failure to get results would normally result in serious program delays, considerable expenditure of dollars, and resources and regulatory risk to the company.

6. Some travel is required.

7. High degree of confidentiality and ethics

8. Foreign language skills a plus

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