|部署・役職名||Japan Regulatory Affair Manager|
This position is key to our Japan business.
We are looking for a strong, independent Regulatory Affairs expert to join our team as Japan Manager.
The selected candidate shall be esponsible for supporting Associate Director Regulatory Affairs EMEA/Japan to ensure compliance with regulations and statutes concerning development, manufacturing, distribution, marketing and sales of our company’s products in Japan.
He/ she shall also develop creative approaches and strategies to solve regulatory problems and support Our company’s marketing and business initiatives.
Reporting to Associate Director Regulatory Affairs EMEA/Japan in Global HQ, English is used often.
Principal Duties and Responsibilities
• General Regulatory leadership － advise business on compliance with applicable regulations.
Provide regulatory reviews and assessments of product concepts, marketing claims and strategies, label copy, product formulas and ingredients and advice on any issues and potential liability. Work with Associate Director, Regulatory Affairs EMEA/Japan, to develop regulatory strategy and priorities. Provide training to the business on the regulatory regime and enforcement environment. Use knowledge of regulatory processes and procedures to counsel clients in devising strategies to remove barriers to successful product introductions.
• Product Label ＆ data management: Develop and review technical label copy based on formula recipe; review product labels/ artworks in a timely manner and assure compliance with applicable Codes, Regulations and Laws.
• Manage regulatory product information in Our company’s databases
• Assure correctness of the regulatory information that appear on Our company’s website
• Regulatory Vigilance － stay abreast of regulatory developments in Japan, share information and coordinate approach with Associate Director Regulatory Affairs EMEA/Japan. Monitor changes in the regulatory environment; advise and make recommendations to management as to the impact of regulatory changes. Build, foster and maintain appropriate and effective relationships with key regulatory agencies （e.g., MAFF, AQS）. Address and defend regulatory challenges that arise.
• Industry Trade Associations – represents Our company’s in the regulatory Committees and at the board level of the key trade associations in Japan. Build, foster and maintain strong working relationships and influence Associations’ strategy and decision making on Our company’s behalf.
• Product Development Support － review product formulations and ingredient specifications for compliance in Japan. Provide timely regulatory assessments of project proposals for changes to existing products or new products.
【必須（MUST）】o Bachelors of Science in Biology, Chemistry or nutrition related field.
o In－depth experience in Regulatory Affairs dealing with governmental and regulatory agencies in Japan.
o 10＋ years of experience in the feed, food, medical device, cosmetic / consumer product, veterinary product or pharmaceutical industry involved in labeling, ingredients, product claims and support, product registrations or submissions, and other regulatory－related matters.
o Possess thorough knowledge of local regulatory requirements relevant to responsibilities.