- Manage regulatory activities for development and marketed products (through third parties if applicable)
- Plan and execute regulatory strategies with global regulatory affairs related to development, new drug application(s) and marketing authorization maintenance that maximize value for patients in the assigned areas. Evaluate regulatory impact of new regulations and intelligence with respect to products in development and/or approved Jazz products in Japan.
- Manages both small molecule and biologics products.
- Execute new product registration and lifecycle management regulatory procedures.
- In collaboration with global team, develop and implement Japan regulatory submission (including CMC) strategies and timeline; work collaboratively with cross-functional teams and communicate Japan strategies and timeline as needed.
- Managing the preparation and review of Module 1.2, Module 2 and 3 CTD sections of regulatory submissions (Japan NDAs, Japan PCAs, Japan MCNs, Japan CTNs, PMDA/MHLW meeting requests, and briefing documents), documents for Manufacturing License or Foreign Manufacturer Accreditation, GMP inspection and necessary licenses in post-marketing phase, as assigned, in support of Global Regulatory Team.
- Coordinate the preparation and timely submission of responses to regulatory agencies. Manage timelines to ensure approvals are timely and development objectives are met.
- May act as regulatory Japan RA CMC representative at meetings with business partners and may contributed to meetings with regulatory agencies for CMC related issues.
- Ensure continued regulatory compliance of products though adherence to the change control procedures, regulatory information management procedures and completion of regulatory impact assessments for assigned commercial and development products.
- Maintenance of current regulatory product information to support product release for assigned commercial products. Verify electronic publishing of regulatory submissions.
- In collaboration with global team conduct regulatory risk assessment, identify key CMC regulatory issues and mitigation activities on Japan regulatory submissions.
- At CTN stage, receive CMC information and provide gap analysis per Japan specific CMC requirements to global team.
- At NDA stage, receive core dossier and provide gap analysis per Japan specific CMC requirements.
- Fill out Japan local forms, proof-reading translation of the dossier and any Health Authority questions. Interpret Health Authority questions and work with global product team to address.
- Provide change control regulatory impact assessment as required.
- Manage and analyze proper CMC requirements as well as communicating with stakeholders to match company objectives.
- Develop proper writing of manufacturing methods and specifications and testing method description for Japanese NDA submission.
- Take the lead in PMDA consultation, NDA and PCA/MCN submission and review process management.
- Communicate with regulatory authorities, . MHLW and PMDA to gain approval and implement changes and in support of inspections
- Identify & support continuous improvement opportunities for the Japan RA CMC and the broader GRA team.
- Ensure compliance with company policies, procedures, and training expectations.
- Minimum 10 years of related pharmaceutical industry regulatory experience, including RA CMC.
- Awareness and familiarity with industry principles of drug development.
- Demonstrated understanding and strategic application of regulations and guidelines for drug lifecycle.
- In-depth knowledge of ICH requirements and Japan regulatory requirements, especially in CMC.
- Experience of leading Japan Health Authority interactions, CTN, NDA, post-approval preparation, submission, and subsequent response to HA queries.
- Experience in authoring Japan CMC related NDA submission documents and life cycle management.
- Experience in regulatory administrative procedures in NDA and life cycle management. (. license, GMP inspection, Gateway, eCTD publishing)
- Ability to prioritize and handle multiple projects simultaneously.
- Ability to negotiate and communicate with internal and external customers.
- Good sensitivity of potential risk and risk management in business compliance and quality
- Strong interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators.
- Ability to create Japanese scientific documents with communication skills with multiple stakeholders both internally and externally including Japanese Health Authorities.
- Demonstrated experience in effective communication.
- Strong negotiating skills and ability to think creatively and develop creative solutions.
- Native level in Japanese and sufficient English level (speaking & writing English) to achieve communication/discussion with global team is required.
- Leadership skills and ability to work in a team.
- Strong PC literacy is required; MS Office skills (Outlook, Word, Excel, PowerPoint)
- Pharmacist license (preferable)
- Education Required: BS Degree in scientific discipline , MS/PhD preferred.
- Familiar with Veeva Vault system (preferable)
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Senior Manager, Regulatory Affairs, Japan - Chiyoda, 日本 - Jazz Pharmaceuticals
2日前
説明
JOB PURPOSE
The Manger, Regulatory Affairs, Japan shall manage regulatory activities assigned in GW Pharma order to obtain new drug application(NDA) approval, partial change application(PCA) approval, to submit appropriate minor change notification(MCN) and to execute other necessary regulatory procedures including but not limited to license management, in compliance with applicable regulations.
KEY RESPONSIBILITIES/ACCOUNTABILITIES
DETAILED RESPONSIBILITIES/ACCOUNTABILITIES
KEY ATTRIBUTES/SKILLS/EDUCATION – ESSENTIAL Attributes
KEY ATTRIBUTES/SKILLS/EDUCATION – DESIRABLE
