【必須要件】
・他社での薬事経験もしくは当局での審査業務に従事した経験
・英語・日本語でのコミュニケーション能力
・米国・欧州の薬事規制に対する知識、経験
【望ましい要件】
・グローバルでの申請経験(特に欧米)
・バイオ医薬品での開発・薬事経験
・IFPMA等の業界活動経験
[Essential criteria]
- Experience in pharmaceutical affairs at another company or involvement in regulatory review work at an authority.
- Communication skills in English and Japanese.
- Knowledge and experience in pharmaceutical regulations in the US and EU.
[Desirable criteria]
- Experience in global applications, particularly in the US and EU.
- Experience in development and/or regulatory affairs in the field of biopharmaceuticals.
- Industry involvement in organizations such as IFPMA.