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Associate Director, RA Policy ＆ Intelligence Japan
年収：1100万 ～ 1500万
採用企業案件
ヤンセンファーマ株式会社
-
- 会社規模501-5000人
- 医薬品メーカー
| 部署・役職名 | Associate Director, RA Policy ＆ Intelligence Japan |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
■POSITION SUMMARY: Briefly state the objective of this position. Drive and manages the activities of Regulatory Intelligence as the representative of Japan RA and related Japanese function within R&D, such as proactively driving Industry Association or Health Authority (HA) interactions to successfully develop the Janssen compounds or raise Japanese presence among industry or to HA. Lead and administrate the strategical discussion from the perspective of the contribution to both of public health and our business. Lead the identification of regulatory and legislative trends and issues that have the potential to impact the development and marketing of pharmaceutical products within Japan and provide high quality strategic input aimed at influencing the future regulation. Japan Regulatory Policy Lead to engage in direct regulatory advocacy and influencing activities relating to regulatory healthcare policies partnering with stakeholders including local subject matter experts and AP/GRPI . This is accomplished through a variety of activities, including participation in Trade Association initiatives, Health Authority meetings and consultation as well as contribution to commenting on new legislation and guidance. ■PRINCIPAL RESPONSIBILITIES: List major responsibilities and duties of the position. (Start the description with a verb) Regulatory Policy Japan Expertise ・Provide leadership for proactive & reactive policy development internally and externally ・Provide leadership for key Trade Associations and Professional Organizations ・Provide expert advice on and interpretation of key regulatory policy issues affecting local environment ・Develop effective approaches to and participate in Trade Association Committees and Initiatives, Professional Organizations activities and Health Authorities meetings and consultations. Advice and Cooperative to RCLs activities for policy focused projects (ex, Regenerative medical products etc) ・Attend and provide feedback to RCLs and R&D members on current regulatory guidelines and procedures as well as emerging regulatory/legislative issues that impact or affect products. ・Attend and provide feedback to RCLs and R&D members on local regulation of new business area. ・Collect opinions from R&D activities and liaise with Trade Associations to bring them up to Working Group with HAs Cooperative to regulatory policy and intelligence based on Japan regulation to AP/GRPI, R&D and JJ MedTech ・Collaborate and partner with AP/GRPI and Japan RA/R&D members to ensure effective and timely dissemination of Regional Regulatory Information, Intelligence and Knowledge ・Collaborate regulatory members in JJKK to share Regional Regulatory Information, Intelligence and Knowledge Negotiation with HA, KOL and stakeholder for suitable issue. ・Establish network of MHLW/PMDA and KOL for focused area (ex. regenerative medical products, new regulation etc) Support internal functions through training on specific regulatory intelligence issues ■REPORTING RELATIONSHIPS: Describe where this position fits in relation to the rest of the department it resides. Japan Regulatory Affairs: Director, Japan RA TA-Group Leader |
| 応募資格 |
【必須（MUST）】 ・Minimum of bachelor’s degree or equivalent in pharmacy or life-science or health-related discipline・Minimum of 8 years of overall experience in R&D in pharmaceutical industry (including 2+ years of regulatory experience) or in health authorities OR Masters/ PharmD and 6+ years, PhD and 4+ years ・Working knowledge of regulations in Japan and/or experience of regulatory in product approval and licensing. ・Excellent working knowledge of the regional regulatory framework and how that applies to pharmaceutical product development. ・Excellent verbal and written communications skills in Japanese and English ・Extensive experience in regulatory policy activities in industry or trade associations. ・Experience in HAs interactions ・Highly developed network amongst local regulators and other key associations and organizations. ・Knowledge of regulatory texts, legal texts and extensive experience of regulatory affairs. |
| アピールポイント | 管理職・マネージャー 完全土日休み |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2024/12/10 |
| 求人番号 | 3813337 |
採用企業情報
- ヤンセンファーマ株式会社
-
- 会社規模501-5000人
- 医薬品メーカー
-
会社概要
私たちヤンセンファーマは、世界最大級のトータル・ヘルスケア・カンパニー、
ジョンソン・エンド・ジョンソン（J＆J）グループの製薬会社として、いまだ
満たされていない医療ニーズに迅速に応え、最先端の医薬品を一刻も早く患者
さんの手元に届けることができるよう取り組んでいます。
私たちは、世界57ケ国200社以上に及ぶJ＆Jグループを貫く経営理念「我が信条
（Our Credo）」を志とし、さらに、46年間に84品目もの新薬を開発したヤンセ
ン・ファーマスーティカ社の創業者、ポール・ヤンセン博士の妥協なき開発精
神を継承し、J＆Jグループの優れた新薬の導入はもちろん、医療現場への適切
かつ最新の医療情報の提供、さらには、患者さんのＱＯＬ（クオリティ・オブ・
ライフ）の向上を目指した支援活動などをおこなっています。
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です