メディカル・バイオ - 薬事申請

新薬承認申請業務
※詳細は担当者にご確認ください

■休日：完全週休二日制, 土, 日, 祝日

Who You Are:
Qualifications
・Bachelor’s degree (scientific or clinical background desirable) required; advanced degree preferred.
・Minimum 7 years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry required for Associate Director; Minimum 5 years of Regulatory Affairs experience for Senior Manager.
・Experience with managing CTN, PMDA consultation and marketing authorization applications (e.g. J-NDA).
・Experience with preparation and review of electronic format (eCTD) submissions
・Direct interactions with PMDA/MHLW
・Experience in submission writing and review experience are essential.
・Experience with Orphan Designation and/or Expedited Programs for Serious Conditions (Designation of SENKUTEKI-Iyakuhin, Priority Review Designation, etc.) preferred.
・Experience with post-approval regulatory activities such as Japan Package Insert/MAH License maintenance etc. preferred.
・Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter.
・Strong interpersonal skills to collaborate effectively across multiple functional areas.
・Excellent/business level communication skills in Japanese/Englich (verbal and written).
・Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.
・A bias towards action combined with high ethical standards is essential.
・Initiative, combined with a high energy level is critical to success.
・Must successfully exhibit Insmed’s five (5) core corporate values of: Collaboration Accountability, Passion, Respect and Integrity; along with any other position specific competencies.
・Must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

■職種未経験者：不可