Sr. Scientist, Regulatory Liaison
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Job Location:
Monthly Salary:
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
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 morePreferred 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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
03/31/2026*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Senior IC
Key Skills
- Presentation Skills
- Time Management
- Clinical Research
- Communication skills
- GCP
- Infusion Experience
- Managed Care
- Hospice Care
- Conflict Management
- Clinical Trials
- Research Experience
- Home Care
About Company
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicine ... View more
