R&D CMC Regulatory Affairs Biologics

1ヶ月前

Chiyoda MSD Full time

Job Description

グローバル研究開発本部 薬事領域スタッフとして、バイオ医薬品・ワクチン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。

[職務内容]

  • 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。

[応募資格]

必要な資格、資質

  • CMCラボ・パイロットでの原薬・製剤又は分析の実務経験、あるいはCMC薬事実務経験
  • 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

  • 海外とのコミュニケーション経験

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

As a staff member of CMC Regulatory Affairs Department of Japan Development Division, a person in charge who is willing to contribute in CMC Regulatory Affairs (RA) tasks from initial stage of new drug development to NDA filing and the approval, addition of dosage form, and change controls. We can offer a range of opportunities to experience product development with a cutting-edge CMC technology and/or to be in front line of discussion on regulatory CMC topics which are focused on in the pharmaceutical industry.

[ Job Description ]

  • Collaborate with our company HQ CMC RA members to appropriately advance the CMC development stage of the project in charge, and prepare CTD CMC parts (i.e. Manufacturing method, Specifications and test methods, and Stability) logically with high scientific quality.
  • Identify product issues and assess risks from the CMC viewpoint, and plan countermeasures.
  • Provide CMC-RA information obtained from regulatory authorities or industry associations to Japan/overseas relevant divisions, and discuss with them.
  • Evaluate CMC related changes and take appropriate RA action, if necessary.
  • Appropriately respond to questions from the authorities on consultations or on review for approval, or negotiate if necessary.
  • Cooperate with our company HQ or overseas sites through overseas business trips or teleconference to prepare the strategic countermeasures on CMC relating matters.

[Qualifications]

Required Qualifications

  • Experience at CMC labs or pilot facility of Drug Substances/Drug Products, or Analyses, or CMC Regulatory Affairs.
  • Master's degree or above, in medicine, pharmacy, chemistry, or biology.
  • Practical English speaking ability (TOEIC score 700 and over).

Desired Qualifications

  • Experience of commutation with overseas

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:

Domestic

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:12/31/2024

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.

Requisition ID:R286744

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