CMC薬事マネージャー

Job Details

<求人タイトル>

17708 CMC薬事マネージャー

<職務内容>

Responsibilities:
・Responsible for stakeholder management to achieve high quality RA CMC deliverables in collaboration with HQ, partner companies.
・Responsible for supervising and ensuring QA activities as QA Manager in collaboration with Commercial department
・Responsible for preparing and maintaining of Drug Master File (DMF), Foreign drug Manufacturer Accreditation (FMA) and Japan Approved Name (JAN)
・Responsible for communication with regulatory authorities as RA contact person to ensure Clinical Trial Notification (CTN) and Investigational Material Product (IMP) handling for clinical studies
・Responsible for establishing MAH organization to ensure quality function for J-NDA

Tasks:
・Generate high quality RA related deliveries (ex. CTN, DMF, FMA, JAN and J-NDA) in collaboration with stakeholders
・Maintain as a QA Manager for MAH license and product Marketed by the company and where the MAH is the company
・Handling and maintaining regulatory CMC activities related to Japan (ex. In-country caretaker for DMF and FMA and co-promotion) in collaboration with the HQ and partners
・Ensure clinical study initiation in Japan, (i.e. CTN process)
・Ensure IMP handling collaborate with IMP manager and third parties for clinical trials as Local IMP manager
・Contribute to establish MAH organization, especially quality function for J-NDA

<応募要件>

・Pharmacist is preferable
・Bachelor’s degree (scientific background) required, and advanced degree preferred
・Experience QA Manager within the Pharmaceutical industry or CRO
・Minimum 8 years Regulatory Affairs Experience in Pharmaceutical industry or CRO
・Successful creation and submission of CMC CTD dossiers of Biologics products for JNDA
・Experience DMF, FMA renewal and JAN
・Experience of IMP handling for the clinical trials
・Experience with the PMDA (CMC) interactions
・English skill (verbal and written)
・Must have excellent communication and presentation skills (Japanese / English)
・Flexible, diplomatic and able to effectively deal with ambiguity
・Work effectively across functions as a team player

<会社概要>

精神・神経疾患に特化した外資系製薬企業です。グローバルで多数のパイプラインを抱えており、今後大変成長が期待されるファーマです!

年収:経験・能力による(応相談となります)
就業時間:7.5 時間(09:00-17:30 フレックスタイム有(コアタイム無し))
在宅勤務:試用期間終了後(日数制限なし)

<注目ポイント>

現在急成長中のファーマからCMC薬事ポジションのご紹介です!新製品の申請に携わることが可能で、幅広いご経験を身についていただけるやりがいの大きいポジションです。ご興味がございましたら、是非お気軽にお問い合わせください!

Job application