R&D Regulatory Affairs Sr. Scientist（開発薬事）

Job Description

業務内容：

1.     グローバル戦略に沿った、効率的かつ付加価値の高い新薬等の国内開発薬事戦略の構築

2.     規制当局（厚生労働省、独立行政法人医薬品医療機器 総合機構など）との窓口業務

3.     承認申請・審査資料、機構相談資料、照会事項に対する回答等へのレビュー・アドバイスを通じ、当局提出文書の質の向上に資する

4.     承認申請・審査資料、機構相談資料、照会事項に対する回答等の作成・提出のコーディネーション

5.     新薬承認申請に関する薬事情報の収集・分析、関係者への提供／共有

6.     当局対応（30日調査、対面助言、申請準備、審査対応）の際の、米国本社も含めた社内調整（スケジュール管理）

 

必須条件：

＜経歴・経験＞

• 製薬系会社又は医薬品開発に関する勤務経験

• 承認申請・審査対応の経験

• ライフサイエンス系大学院卒以上

＜知識・スキル＞

• 薬学あるいは医学に関する基本的知識

• 英語文献読解、国外担当者とメールでのコミュニケーションができるレベルの英語力

コミュニケーションスキル　

望ましい条件、資質：

＜思考・行動＞

• 前向き

• 論理的思考

• 主体・行動型

＜知識・スキル＞

• 薬機法等薬事規制に関する知識

Job Description

1.         Develop an efficient and high value-added Japan regulatory development strategy in line with global strategies

2.         Responsible as a contact parson with regulatory authorities (MHLW and PMDA, etc.)

3.         Contribute to improving documents quality submitted by authorities through review on CTD, PMDA consultation documents, responses to inquiries, etc.

4. Coordination of preparation and submission of NDA, PMDA consultation, responses to inquiries, etc.

5.         Collection and analysis of regulatory information on NDA etc. and sharing to relevant parties

6.         Coordination including HQ when interacting authorities (30-days review, PMDA consultation, NDA submission, NDA review)

 

Required Qualifications

• Experience working at a pharmaceutical company or company related to pharmaceutical development

• Filing/Review experiences

• Master of Life Sciences or above

• Basic knowledge about pharmacy or medicine

• English skill at a level capable of reading English literature and communicating by email with overseas

• Communication skills

 

Desired Qualifications

• Positive

• Logical thinking

• Initiative / action type

Knowledge of Pharmaceutical Affairs Regulations

Required Skills:

Accountability, Accountability, Adaptability, Communication, Complaint Management, Data Analysis, Economic Impact Analysis, Interpersonal Communication, Medicinal Chemistry, Negotiation, Parasitology, Pharmaceutical Management, Pharmaceutical Manufacturing, Pharmaceutical Process Engineering, Pharmaceutical Sciences, Pharmaceutical Technologies, Pharmacodynamics, Pharmacogenomics, Pharmacokinetics, Pharmacy Regulation, Process Improvements, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience {+ 4 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

09/30/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.