業種
メーカー
仕事内容
＜会社概要・募集背景＞
アジアを代表する大手化粧品グループの一員として、複数の人気ブランドを展開するグローバルビューティーカンパニー。高品質なスキンケア・メイクアップ・ヘアケア製品を通じて、急速にシェアを拡大しています。
近年はCビューティーブランドとして国内外のメディアでも注目され、その成長を背景に、日本市場への本格進出をスタート。
今回の募集は、日本進出に伴う初の採用ポジション。
東京オフィスの立ち上げメンバーとして、中国本社RAチーム（15名体制）と連携し、海外で製造された化粧品やヘアケア製品が日本の薬事・品質基準に適合するよう体制を構築していただきます。
アジアを代表する成長ブランドの日本展開を担う、非常にやりがいのあるポジションです。
Job Responsibilities
1. Compliance Management
Assist in establishing and maintaining the company's compliance management system for pharmaceuticals, quasi-drugs, and cosmetics, ensuring the entire business process complies with relevant laws and regulations
such as Japan's Pharmaceutical and Medical Device Act, Pharmacist Act, and Cosmetics Act; track updates to
laws and regulations, identify compliance risks, and develop response strategies.
2.Registration and Filing
Responsible for the registration and filing of pharmaceuticals, quasi-drugs, and cosmetics in Japan, including
the collection, organization, drafting, and submission of materials (e.g., PMDA application documents for
pharmaceuticals, filing materials under the Cosmetics Act); follow up on approval progress, and communicate
with regulatory authorities such as the Ministry of Health, Labour and Welfare (MHLW) and PMDA
(Pharmaceuticals and Medical Devices Agency) on application-related issues; manage the maintenance,
modification, and renewal applications of product registration certificates and filing documents to ensure
their validity; organize and archive registration and filing documents, establish and improve a registration
information database, and regularly update product registration status.
3.Government Relations
Establish and maintain good communication channels with Japanese government and regulatory authorities
such as MHLW, local health departments, and PMDA, conducting regular business docking and information
exchanges; track policy trends of regulatory authorities, industry supervision dynamics, and inspection
priorities, timely communicate relevant information to the company's internal departments and propose
response suggestions; assist in handling on-site inspections, inquiries, and investigations by regulatory
authorities, prepare inspection materials, and cooperate in completing rectification and feedback; participate
in exchange activities organized by industry associations (e.g., Japan Pharmaceutical Manufacturers
Association), maintain the company's industry image, and timely obtain industry policies and technical
trends.
4.Quality Management
Participate in quality supervision and control of product production, warehousing, and circulation links;
formulate quality inspection plans, and conduct regular quality sampling inspections of raw materials, semi
finished products, and finished products; draft quality analysis reports, identify the root causes of quality
problems, track the implementation of rectification measures, and verify their effectiveness; assist in
establishing and optimizing quality management system documents (e.g., SOPs, quality manuals) to ensure
the effective operation of the system and compliance with relevant certifications (e.g., GMP).
5.Safety Management
Responsible for the collection (including customer feedback, adverse event reports, etc.), classification, and
data analysis of post-marketing product safety information; timely report adverse events to MHLW and PMDA
in accordance with the requirements of the Pharmaceutical and Medical Device Act, and assist in conducting
adverse event investigations and evaluations; formulate product risk prevention and control plans, handle
customer quality complaints, promote relevant departments to implement improvement measures, and
improve product safety levels.
6.Documentation and Training
Responsible for the organization, archiving, storage, and version control of quality and compliance-related
documents (inspection records, compliance reports, registration materials, system documents, etc.) to ensure
the completeness and traceability of documents; assist in formulating internal compliance and quality
training plans, develop training courses (e.g., interpretation of laws and regulations, quality management
processes, adverse event reporting standards), organize training, and evaluate training effects.
7.Cross-departmental Collaboration
Maintain close communication with production, sales, R&D, procurement, and other departments, providing
professional support for compliance and quality (e.g., compliance guidance during the R&D phase, quality risk
reminders during the sales phase); participate in cross-departmental project meetings, coordinate and solve compliance and quality problems in business processes, and ensure synergy in all links meets regulatory
requirements.
