【国内グローバル求人】Manager or Specialist, Regulatory Affairs / Quality Assurance [022]
業種
メーカー
場所
東京都内
給料
• Salary Range: Negotiable (based on education, qualifications, and work experience)
• Welfare Benefits:
o Comprehensive social insurance (health insurance, employees' pension insurance, employment insurance, industrial accident insurance);
o Annual leave (starting from 10 days in the first year, increasing year by year), summer vacation, year-end and New Year holidays;
o Transportation allowance (reimbursed based on actual expenses, maximum 30,000 yen/month), communication allowance, housing allowance;
o Health check-up, employee welfare system (e.g., commuter bus, employee discounts).
• Career Development: Provide internal promotion channels, and support participation in industry training and qualification exam tutoring.
• Welfare Benefits:
o Comprehensive social insurance (health insurance, employees' pension insurance, employment insurance, industrial accident insurance);
o Annual leave (starting from 10 days in the first year, increasing year by year), summer vacation, year-end and New Year holidays;
o Transportation allowance (reimbursed based on actual expenses, maximum 30,000 yen/month), communication allowance, housing allowance;
o Health check-up, employee welfare system (e.g., commuter bus, employee discounts).
• Career Development: Provide internal promotion channels, and support participation in industry training and qualification exam tutoring.
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
Establish and maintain compliance management systems for pharmaceuticals, quasi-drugs, and cosmetics.
Ensure full adherence to Japan’s Pharmaceutical and Medical Device Act and relevant regulations.
Track regulatory updates, identify compliance risks, and propose countermeasures.
2. Registration and Filing
Handle product registration and filing with Japanese authorities (MHLW, PMDA).
Prepare and submit regulatory documents, monitor approval progress, and maintain registration records.
Manage certificate renewals and maintain an updated product registration database.
3. Government Relations
Build and maintain strong relationships with regulatory authorities (MHLW, PMDA, local health offices).
Monitor policy trends and share updates with internal teams.
Support on-site inspections and audits from government bodies.
4. Quality Management
Oversee quality control across production, storage, and distribution processes.
Conduct sampling inspections, analyze quality issues, and verify corrective actions.
Develop and optimize SOPs and quality manuals in line with GMP standards.
5. Safety Management
Collect and analyze post-marketing safety data and adverse event reports.
Report adverse events in accordance with local regulations and coordinate investigations.
Implement risk mitigation and improvement measures to enhance product safety.
6. Documentation and Training
Manage documentation and version control for all compliance and quality records.
Develop and deliver internal training on regulatory and quality topics.
7. Cross-functional Collaboration
Work closely with production, sales, R&D, and procurement teams.
Provide compliance and quality support across the product lifecycle.
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
Establish and maintain compliance management systems for pharmaceuticals, quasi-drugs, and cosmetics.
Ensure full adherence to Japan’s Pharmaceutical and Medical Device Act and relevant regulations.
Track regulatory updates, identify compliance risks, and propose countermeasures.
2. Registration and Filing
Handle product registration and filing with Japanese authorities (MHLW, PMDA).
Prepare and submit regulatory documents, monitor approval progress, and maintain registration records.
Manage certificate renewals and maintain an updated product registration database.
3. Government Relations
Build and maintain strong relationships with regulatory authorities (MHLW, PMDA, local health offices).
Monitor policy trends and share updates with internal teams.
Support on-site inspections and audits from government bodies.
4. Quality Management
Oversee quality control across production, storage, and distribution processes.
Conduct sampling inspections, analyze quality issues, and verify corrective actions.
Develop and optimize SOPs and quality manuals in line with GMP standards.
5. Safety Management
Collect and analyze post-marketing safety data and adverse event reports.
Report adverse events in accordance with local regulations and coordinate investigations.
Implement risk mitigation and improvement measures to enhance product safety.
6. Documentation and Training
Manage documentation and version control for all compliance and quality records.
Develop and deliver internal training on regulatory and quality topics.
7. Cross-functional Collaboration
Work closely with production, sales, R&D, and procurement teams.
Provide compliance and quality support across the product lifecycle.
応募資格
Language
・Fluent in Business Japanese (mandatory)
・English reading/writing proficiency preferred
Qualifications / Experience
・Bachelor’s degree or higher in Pharmacy, Chemistry, or related fields
・Minimum 3 years of experience in Regulatory Affairs or Quality Assurance in pharmaceuticals, quasi-drugs, or cosmetics
・Japanese Pharmacist License preferred
・Strong logical thinking, communication, and problem-solving skills
・Fluent in Business Japanese (mandatory)
・English reading/writing proficiency preferred
Qualifications / Experience
・Bachelor’s degree or higher in Pharmacy, Chemistry, or related fields
・Minimum 3 years of experience in Regulatory Affairs or Quality Assurance in pharmaceuticals, quasi-drugs, or cosmetics
・Japanese Pharmacist License preferred
・Strong logical thinking, communication, and problem-solving skills
求人番号
JPN25-10-19KIN1
