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薬事マネージャー
年収：800万 ～ 1300万
採用企業案件
役員面接
グローバルレギュラトリーパートナーズ合同会社
-
- 会社規模1-30人
- 医薬品メーカー
| 部署・役職名 | 薬事マネージャー |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
Position overview We are searching for an experienced Regulatory Affairs Manager in Pharmaceuticals for our office in Japan. The successful candidate should have at least three years’ experience in Regulatory Affairs with Pharmaceuticals and has submitted and has interacted with PMDA in previous occasions. The RA specialist will support compiling and registering pharmaceuticals with PMDA with the supervision of the CEO. Responsabilities - Maintaining GRP GK MAH Licenses (Renewal and updates) - Updating GVP and GQP SOPs as needed. - Managing the quality and pharmacovigilance activities at GRP GK - Providing the necessary information on regulations and products necessary for the development of the regulatory strategy of different products in Japan. - Preparing the registration dossiers in for CTA, JNDA and DMF as necessary. - Preparing consultation meeting with PMDA including the preparation of the meeting packages. - Reporting to GRP Headquarters any changes in the Japan regulations that can affect GRP business or its clients’ business or products in Japan. - Performing quality control checks for submission ready documents. - Participating in regulatory-clinical cross functional team meetings and project teams. - Preparing responses to regulatory agencies' questions and other correspondence. - developing timelines for submissions under the direction of senior regulatory affairs management. - Providing Regulatory Affairs support during internal and external audits. - Defining regulatory deliverables for each project and monitoring projects through completion - Updating GVP and GQP SOPs as needed. - Supervising the quality of products in Japan, including the products release to the market. - Review and/or approve labelling to ensure they are documented and produced in compliance to domestic internal requirements on GQP/GVP. |
| 労働条件 |
契約期間：期間の定めなし 試用期間：あり（3カ月） 就業時間：9:00～18:00（休憩1時間） 休日 ：土日、祝日 休暇 ：年次有給休暇/年末年始/慶弔 残業 ：あり 給与 ：詳細は面談の時にお伝えします 通勤手当：会社規定に基づき支給（上限月額30,000円） 社会保険：健康保険、厚生年金、労災保険、雇用保険 |
| 応募資格 |
【必須（MUST）】 - Pharmacist- 3 years or more of experience in regulatory affairs for Pharmaceuticals. - Experience with communication with PMDA or notified body reviewers. - Good communication skills in English （written and oral） - Sufficient PC skills to administer regulatory datasets and their revisions - Excellent team player Preferred - 3 yrs. or more of experiences as one or more of representative of Pharmaceuticals MAH （Sokatsu Hinseki or Anseki） - Experience in managing regulatory projects - Experience in managing other regulatory people - 3 years or more experience in quality control of pharmaceuticals and or pharmacovigilance - Facilitator - Good analytical and problem-solving skill - Self-motivator and self-learner - Minimum English Level: Daily Conversation - Minimum Japanese Level: Native |
| アピールポイント | 管理職・マネージャー 完全土日休み |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2023/08/08 |
| 求人番号 | 2885730 |
採用企業情報
- グローバルレギュラトリーパートナーズ合同会社
-
- 会社規模1-30人
- 医薬品メーカー
-
会社概要
【設立年月日】2016年10月25日
【本社所在地】東京都港区虎ノ門5丁目13-1
【事業内容】
外資系医療機器および医薬品メーカー向け製造販売業務、コンサルティング業務
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です