Manager, Regulatory Affairsの求人情報なら転職エージェントJAC

求人情報

Manager, Regulatory Affairs

  • 転勤なし
  • 週休二日制
  • 外資
求人番号

NJB997191

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会社名 外資製薬メーカー <業種:メディカル・バイオ - 製薬>
職種

メディカル・バイオ-薬事申請

雇用形態 正社員(期間の定めなし)
勤務地 東京都
仕事内容

1. Work with submission team in Japan and Global to implement Japan regulatory strategy plans for products for both investigational and marketed products

2. Participate in or lead Japan submission team and relating sub-team (project team) for assigned product(s) / project(s)

3. Create, lead and review major regulatory applications (eg. CTNs, Briefing Documents for PMDA consultation, Orphan Drug Applications, Marketing Approval Applications, etc.)

4. Participate in and/or lead regulatory interactions with MHLW/PMDA on assigned projects.

5. Participate or acts as regulatory representative on various cross-functional teams

6. Participate in cross-functional initiatives

7. Maintain and reinforces compliance with Company SOPs and Work practices

8. Provide input and comments on draft regulatory guidance

9. Create NHI pricing strategy of new products and to prepare necessary documents to MHLW.


■休日:完全週休二日制

求める経験、能力
年齢制限の理由

・Bachelors degree in scientific discipline; Advanced scientific degree preferred.

・More than 10 years pharmaceutical industry experience, including more than 5 years in regulatory affairs experience.

・Thorough knowledge of the Japanese drug development process, CTN, PMDA consultation, NDA and NHI pricing process.

・Demonstrated experience in preparing Japan submissions.

・Good Understanding of the drug development process.

・Specific expert knowledge in one or more key areas expected: Oncology Drug Development / CMC / PK / Clinical / Promotional


■職種未経験者:不可

年収 800万円 - 1200万円
語学力
英語力: 
中級

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