CooperVision Japan (CVJ) is the largest operating business in the APAC region, based in Tokyo and is the second largest single country businesses in worldwide. Japan RA Senior Specialist (hereinafter referred as the RA Senior Specialist) shall be responsible for contributing and leading the Regulatory Affairs (RA) for the CooperVision Japan business. This individual is expected to be a strong assistant to the RA Manager and partner to Quality Assurance (QA) team, Vigilance team in Japan RAQA department and a proactive business partner to the Japan commercial team. The RA Senior Specialist shall follow the regulatory strategy for assigned corporate projects and obtains approvals for the Japan regulatory submissions. The RA Senior Specialist shall be responsible for all non-clinical studies required to demonstrate the safety and efficacy of contact lenses, which are classified as Class III high-risk medical devices in Japan. The focus of the role will be to exercise the leadership to translate regulatory requirements and CV NPI pipeline into practical, innovative, workable, solutions-oriented plans via interacting directly with the local health authorities MHLW and PMDA, the Global RA/R&D. 1. Establishment of non-clinical study strategies with global RA and R&D by harmonized approach to reduce the study cost and study period for early regulatory approval. 2. Assessment of global standards and local requirements and evaluation of CVI non-clinical study data for preparation of regulatory submission dossier. 3. Coordinate internal and external non-clinical studies for Japanese submission in collaboration with global RA, R&D and local external lab. 4. Consultation with local health authorities prior to submission and response to post-submission inquiries to ensure early approval. 5. Share non-clinical knowledge and information with the global and regional RA team to support the development of the organization's skills. Participate in both Ophthalmic industry and Medical Device professional societies and working groups to influence the direction of both regulations and or guidance documents. The RA Senior Specialist shall engage in his/her own talent development to ensure the continued business grow.

【具体的な業務内容】

1. 製品登録・ライセンス

 国内における規制要件や国際基準を常に把握し、遵守を徹底する。

 自社ブランド、OEMブランド、プライベートブランドのコンタクトレンズについて、保健当局から製品ライセンス承認を取得する。

 必要な製品登録、ライセンス更新、変更通知の作成・提出を確実に行う。

 日本の保健当局との主要な窓口として対応する。

 グローバルRA/R&D、新製品導入(NPI)チームなどと連携し、規制申請に必要な技術資料や情報を準備・取得する。

 グローバルR&Dと協力し、主に物理・化学・生物学的安全性試験などの非臨床分野をリードする。

 日本RAQAのVigilanceチームと連携し、製品ラベルや使用説明書(IFU)が現地規制に準拠していることを確認・承認する。

 日本のマーケティング/プロフェッショナルアフェアーズチームを支援し、広告・販促資料(Ad/Promo)のレビューおよび承認を行う。

 国内外の規制、ガイドライン、業界標準の変更を監視し、クーパービジョン・ジャパンのビジネスやグローバル/リージョナルRAへの 影響を評価。ギャップ分析や規制戦略を策定し、必要なアクションプランをグローバルRAと協力して実施する。

 NPIにおける規制影響文書(RAIDS)を通じて、日本の現地要件をグローバルRAに提供する。

 GCPおよび関連規制に準拠した臨床試験の実施を支援し、必要な知識を習得する。

 グローバル/リージョナルRAチームのプロジェクトをサポートする。

2. その他業務

 各種レポートの作成。

 業務関連システムへのデータ入力・更新。

 スポット的に発生するプロジェクトへの参加。

 RAマネージャーと協力の上、非臨床業務関連トレーニングの実施・運営(部内向け)。

商用出張(海外/国内):年間約5~10%

1. Product registration / licenses 
   1. Keeps abreast and ensure compliance with the regulatory requirements and international standards within the local country. 
   2. Ensures product license approvals for "Own Brand", "Original Equipment Manufacturer" brand and "Private label" brand contact lenses obtained from local health authorities.
   3. Ensures development and submission of all required product registrations, license renewal and change notification to local health authorities. 
   4. Serves as a primary liaison with local health authorities in Japan. 
   5. Collaborates with Global RA/R&D, Global New Product Introduction (NPI) and other team members to prepare/obtain technical dossiers and information in support of regulatory filings/submissions. 
   6. Collaborates with Global R&D and leads non-clinical areas such as the physical/Chemical and biological safety studies mainly. 
   7. Review and approval of product labelling and IFUs to ensure compliance with applicable local regulations with collaboration with Vigilance team in Japan RAQA. 
   8. Supports Japan Marketing/Professional Affairs teams on the review and approval of advertisement/promotional (Ad/Promo) materials. 
   9. Monitors and communicates changes on international and local regulations, guidance documents and industry standards that impact CV Japan business and Global/Regional Regulatory Affairs. Provides gap assessments and regulatory strategies and collaborates with Global RA on the necessary action plans on these changes. 
   10. Inputs Japan local requirements to Global RA through the process of NPI-Regulatory Affairs Impact Documents (RAIDS) from local country perspective. 
   11. Supports and learns implementation of clinical studies in compliance with GCP and related regulations as required by local health authorities. 
   12. Supports the Global/regional RA teams on the projects. 
        
2. Others 
   1. Ensures relevant RA reports are prepared on a regular basis. 
   2. Ensures relevant Global RA systems are updated. 
   3. Participates and involves in any other ad-hoc projects and activities. 
   4. As a SME, leads, trains and develops Japan RAQA team together with RA Manager, as applicable.

知識・スキル・能力(Knowledge, Skills and Abilities)

日本および海外の規制要件に関する深い知識、ならびに製品登録に関する法規制プロセスの理解が必須。

実務経験を通じて習得した眼科製品に関する知識があれば尚可。

高いPCスキル、問題解決能力、分析力、コミュニケーション能力および協働力を有することが必須。

英語および日本語において、読み書きおよび円滑なコミュニケーションができる能力/経験を有すること。

人物像(Personal Attributes)

主体的(Proactive)、柔軟性があり(Flexible)、マルチタスク対応が可能であること。

経験(Experience)

医療機器業界において、Class II~Class IV 製品を含む**海外各国での製品登録業務に関する実務経験を最低5年(理想的には7年)**有すること。

同一企業において3年以上の就業経験があること。

RA(Regulatory Affairs)活動における率性と連携を確保するため、海外拠点・海外関係者との協業経験があれば尚可。

プロジェクト活動への参画、またはリードし、成果を上げた経験があれば尚可。

眼科向け医療機器業界での業務経験があれば尚可。

医療機器製品開発に関する代表的なISO規格の取り扱い経験があれば尚可。

臨床関連業務の経験があれば尚可。

学歴(Education)

化学、 生化学、 薬学、 獣医学、 理学、 工学などの理系分野における学士号(B.A./学士)

※分野は担当領域により異なる

Knowledge, Skills and Abilities:

• Strong knowledge of Japan and international regulatory regulations, and legal product registration processes is required.
•  Ophthalmologic product knowledge acquired through experience is a plus.
• Strong computer skills, problem solving ability, analytical, communication and collaboration skills is required. Must possess the ability/experience to read, write, and communicate effectively in English and Japanese. 
• Personal attributes: Proactive, Flexible, and Multi-tasking.

Experience:

• Minimum 5 years (ideally 7 years) of in-depth and hands-on experience in the medical devices industry dealing with international country registrations including Class II - Class IV devices. 
• Experience working at one company for three years or more. 
• Collaboration with overseas counterparts for ensuring efficiency and collaboration in RA initiatives is a plus. 
• Participation or lead in project activities and achievement of results is a plus. 
• Experience working in the Ophthalmologic medical devices industry is a plus. 
• Experience with representative ISO standards for medical device product development is a plus. 
• Clinical-related experience is a plus.

Education:

Bachelor's Degree (B.A.) in a scientific field such as Chemistry, Biochemistry, Pharmacy, Veterinary Medicine, Science and Engineering (depending on the field)