CMC RA Manager

Job Details

<Job Title>

17708 CMC RA Manager

<Job Descriptions>

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

<Requirements>

・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

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