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Department: LS-QR-RAJ Japan

Report to: Senior Manager, Regulatory Management & Trade Compliance

 

Position:

Regulatory Affairs Expert

Summary:

Apply for Japanese DMF registrations and maintain them to address post-approval changes.

Address any inquiries raised by PMDA or MHLW regarding GMP compliance inspections linked to drug product approval applications.

Maintain business licenses for IVD and medical device businesses.

Apply for the renewal or any changes to foreign manufacturer accreditation.

 

 

Responsibilities:

Communicate effectively with PMDA and MHLW regarding regulatory affairs subjects.

Prepare dossiers and DMFs based on relevant Japanese pharmaceutical laws and notices.

Raise awareness of pharmaceutical regulatory trends to global RA team and Sales team

Knowledge & Skills Desirable to Perform Role:

Knowledge of pharmaceutical regulations in Japan, including the process from new drug development to MHLW approval acquisition (experience in this area is preferred).

Effective communication and negotiation skills in both Japanese (native level) and English (email communication).

Qualifications: Education & Work Experience Desirable to Perform Role:

A four-year university degree in a scientific field.

More than three years of work experience in pharmaceutical regulatory affairs.

Experience interacting and negotiating with PMDA/MHLW is highly desirable.

 

 

募集要項

 

ライフサイエンス事業部　Regulatory Management部強化のため、国内薬事の経験を持たれた方を募集しております。

　国内薬事業務（主に原薬等登録原簿及び外国製造業者認定）を原薬製造所(ドイツ、中国、スイス)、BioReliance 製造所(US, UK)及びMillipore医療機器製造所（アイルランド）等、各Site Regulatoryチームと協業で行います。

Sigma及びMillipore製品、BioRelianceのMCB/WCB保管含めた試験サービス及びCDMOサービス（抗体医薬、ADC, mRNA, ウイルスベクター）に関われる学びができる環境です。

 

配属先：

Regulatory Expert

Position:

 Life Science　Regulatory Management

Reporting line:

Regulatory senior Manager日本人

Location

東京勤務（週２日　在宅ワーク可）

 

職務内容：

DMF新規、変更及び維持管理（原薬及び培地）

・日本MFを考慮したCTD module 2レビュ

・CTDに基づいたMF、一変軽微設定根拠資料及び製造フロー作成

・MF審査対応

海外製造所回答に基づく照会事項対応

・製造実態との定期的齟齬点検

・後発医薬品変更管理事前確認相談

・製販からのGMP適合性調査対応

・製販へのMF変更連絡

外国製造業者認定の代理人としての業務法改正動向確認及びグローバル薬事への展開体外診断用医薬品　承認申請維持管理医療機器認証品　BSI認証維持管理薬監申請

 

応募要件：

・日常的な英文メールのやりとりに拒否反応が無いこと。

・他部署と積極的にコミュニケーションが取れること。

・薬事申請または申請コーディネーター経験が3年以上あること。

・PMDA及び厚労省との照会対応経験があること。

 

 

Recruiting Contact: Maiko Yamasue

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!