Regulatory Affairs Senior Specialist

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 organizations 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510

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 IIClass 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

RARegulatory Affairs活動における効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:

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