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Job Description グローバル研究開発本部 薬事領域スタッフとして、化成品の新薬の開発開始から承認申請及び承認取得、並びに剤形追加及び変更管理に至るまでのCMC薬事業務に貢献していただける担当者を求めています。最先端のCMC技術を取り入れた製品開発や、製薬業界において注目されているCMC薬事関連トピックの協議に最前線で関与できる幅広い機会があります。 米国本社等のCMC薬事担当者と協働し、担当品のCMC開発ステージを適正に前進させ、論理的で科学的に質の高い承認申請資料のCMCパート（製造方法、規格及び試験方法、並びに安定性等）を作成する。 製品に関するCMC上の問題点の抽出及びリスク評価、並びにその対応策の作成を行う。 規制当局又は業界団体より入手したCMC薬事情報を国内・海外関連部門へ提供し、協議を行う。 CMCに係わる変更情報を評価し、必要に応じ適切に薬事対応を行う。 当局相談あるいは承認審査において、適切に照会対応を行い、必要に応じて交渉を行う。 海外出張や電話会議において、米国本社又は海外サイトの関係者と連携し、CMC関連事項の戦略的対応策を作成する。 必要な資格、資質 CMCラボにおける製剤分析業務の実務経験 医学、薬学、化学、生物学等の修士卒以上 実務レベルの英会話能力（TOEIC700以上） 望ましい資格、資質 CMC薬事の実務経験 海外関係者とのコミュニケーション経験 ※今回はR2若しくはR3での採用となります。 Additional location(s) Compensation Information: Required Skills: Action-Oriented, Adverse Event Report, Compliance Investigations, Detail-Oriented, Employee Training Programs, Labeling Compliance, Negotiation, Policy Implementation, Records Retention Management, Regulatory CMC, Regulatory Communications, Regulatory Strategy Development, Regulatory Submissions, Technical Writing 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: 03/31/2027 *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. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. 
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msd
JPN - Tokyo - Chiyoda, Japan
R&D CMC Regulatory Affairs, Chemical Products Sr. Scientist（CMC薬事）.
REMOTESENIOR LEVEL
more at msd.
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