【1200～万円】Regulatory Affairs

【求人No NJB2343210】
新薬承認申請業務
※詳細は担当者にご確認ください

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.