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[Innovative Medicine] R＆D, Specialist/Manager, Regulatory Strategy ＆ Liaison Group, Regulatory Development, Regulatory Affairs
年収：800万 ～ 1300万
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 | [Innovative Medicine] R＆D, Specialist/Manager, Regulatory Strategy ＆ Liaison Group, Regulatory Development, Regulatory Affairs |
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| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
■Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. ■POSITION SUMMARY: ・Lead Japanese regulatory strategy and target labeling in J-CDT, and share the information to the Global Regulatory Team (GRT) ・Lead CTD Preparation Team for J-NDA submission ・Lead Japanese Health Authority (HA) response such as PMDA consultation/ preliminary meeting, MHLW meeting related the development of compound, 30 (14) Day review for J-CTN regarding development plan and submission ・Negotiate with HAs regarding development compound ■PRINCIPAL RESPONSIBILITIES: 【Input regulatory strategy to J-PT】 ・May serve as a regulatory lead at J-PT ・Participates in GRT to provide inputs on Japanese regulatory strategy and target labeling ・Refines Japanese regulatory strategy as new data becomes available and re-assesses as necessary ・Provides input into strategy with respect to clinical study design for local studies. (Provides input into global clinical studies with ・Japanese requirement if needed) ・Develops and updates contingency plans for regulatory strategies as they pertain to Japan ・Provides input on implications for regulatory strategy through participation in J-PT ・Reviews and provides regulatory input on Japanese Investigator Initiated Proposals as required ・Within the context of the global strategy, determines timing, appropriate Japanese strategy and content for Japanese HA meetings of development products. ・Provides input on study design, conduct, and need for any additional studies for Japan ・Provides regulatory strategic and operational support for products by interacting with project teams, reviewing protocols, maintaining CTNs and NDAs (prepare and submit regulatory submissions, protocol amendments, etc) etc. ・Write and revise disease-specific Japanese target labels based on attributes from Japanese Target Product Profile (TPP) and linked to the Clinical Development Plan and the Regulatory Strategy for Japan 【Labeling】 ・Co-lead the Japanese Labeling Working Group in making strategic decisions, including creation of Labeling strategy ・Reviews labeling to ensure adequate documentation supports the Japanese labeling text ・Ensure the target label and labeling strategy conforms to the Regulatory Strategy for Japan ・Responsible for the contribution to development of Japanese labeling strategy and backup strategies for label negotiation for Japan ・Write and revise Japan target labels during development that are aligned to clinical, commercial and regulatory strategies and in response to evolving data 【CTN/NDA Preparation & submission】 ・Provide input to and be accountable for the preparation of dossiers for submission to HA (NDA /CTN) ・Lead the CTD Preparation Team to prepare Common Technical Document (CTD) for Japan ・Defines, generates and submits appropriate data-driven responses to Japanese HA questions ・Manages lifecycle management submissions for additional indication etc. / with clinical study for Japan. ・Provides input to J-CT to define submission plans including timing for new CTN and CTN amendments and HA reporting requirements; CTN submission dossier content, scope and timing ・Provides input to and reviews submission documents to ensure they accurately answer the questions being posed and are consistent with HA commitment for Japan ・Support cross-functional team to respond 30 (14) Day review and amendment for J-CTN 【Response to HAs】 ・Lead strategy for providing responses to PMDA/MHWL questions (ensure alignment with global strategy by collaboration with responsible function for the topic) ・Ensures that responses to PMDA/MHLW questions are handled in a timely manner and in line with the approved product strategy ・Participates in J-PT/CTD Preparation Team to ensure appropriate and timely responses to HA questions. Provides clarification regarding HA questions and provides input to the strategy for responding to HA questions Lead cross-functional team (CTD Preparation Team) to prepare HA responses. 【Relationship with Global Team】 ・Participates in project related GRT meetings by providing Japanese input if required ・Participates in CDT meeting to provide input on Japanese regulatory strategy if required ・Communicate with Global Regulatory Leader / APRA Liaison to exchange information ・Interacts with APRA Liaison to facilitate execution of regulatory strategy (e.g. for co-development with Asia-Pacific countries) 【Regulatory Advice】 ・Supports all regulatory activities associated with the registration and maintenance of new products and line extensions (e.g. additional indications) ・Provides guidance and support to J-CDT on regulatory issues ・Exchanges information on Japanese regulation with appropriate person, e.g. GRL, APRA liaison 【RA Organizational Management】 ・Participates in Regulatory Development Department ext-LT to discuss and manage issues/improvement related to department and RCL work ・Support RA Professionals 【REPORTING RELATIONSHIPS】 JAPAN Regulatory Affairs: Sr Manager, Japan RA TA Leader / Director, Japan RA TA-Group Leader Global: Global Regulatory 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 6 years of overall experience in R&D in pharmaceutical industry (including 2+ years of regulatory experience) or in health authorities OR Masters/PharmD and 4+ years, PhD and 2+ years ・Leadership and contribution to drug development strategies ・Experience in HAs interactions ・Knowledge of regulations in Japan ・Good verbal and written communications skills in Japanese and business-level English skills ・Can develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor. ・Proactive team player, able to take charge and follow-through. Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment. ・Flexibility to accommodate early morning/evening meetings/ teleconferences with different time zones, especially if there is an important topic related to Japan development plan. Preferred Skills: Analytical Reasoning, Business Writing, Coaching, Fact-Based Decision Making, Industry Analysis, Legal Support, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Risk Compliance, Strategic Thinking, Technical Credibility |
| 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 | その他 「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください |
| 更新日 | 2025/12/10 |
| 求人番号 | 6301817 |
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