仕事概要
職種 | 技術職(販売、設計、開発、生産管理)/開発、研究、実験、プロジェクトマネージャー |
---|---|
業種 | 消費財/ 食品、飲料 |
雇用形態 | 未分類 |
ポジションレベル | その他 |
募集人数 | 1名 |
希望入社時期 | - |
必須語学力 |
英語 (流暢に話せるレベル) 日本語 (流暢に話せるレベル) |
活かせる語学 | - |
勤務時間 | その他 |
福利厚生・休暇 | |
ビザ取得支援 | - |
外国人従業員 | - |
仕事詳細
Company Overview
Global Animal Health Care Company
Job Description
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.
Requirements
【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.
Additional Job Information
Please contact Ayu at ayu.santika@rgf-professional.com for further details.
面接について
連絡先
Japan Regulatory Affairs Manager - Animal Health-
RGFタレントソリューションズ株式会社
1100 〜 1500 万円