Manager, Neuroscience & Marketed Products, Regulatory Affairs/ 薬事部 ニューロサイエンス&マーケットプロダクトグループ 課長代理Apply Now Email Me Job ID R0011594 Date posted 09/04/2019 Location: Osaka, Japan
Please note that this job requires native level Japanese language command not only in speaking, but also in business writing and reading.
Takeda is unwavering in our commitment to patients. With the patient at the center of everything we do, we continue to innovate and drive changes that will better their lives - we’re looking for like-minded professionals to join us.
Today, we are the number one pharmaceutical company in Japan and a global industry leader, with approximately 30,000 employees around the world. We are united by our four priorities (patient, trust, reputation and business) and Takeda-ism (Integrity, Fairness, Honesty and Perseverance) , and strive towards better health and a brighter future for people worldwide.
日本開発センター 薬事部 ニューロサイエンス＆マーケットプロダクトグループ／Japan Development Center, Regulatory Affairs Department, Neuroscience & Marketed Products
- Collaborates to define, develop and lead Japan regional strategies to maximize regulatory and patient access success to enable patient access to meaningful medicines in alignment with program objectives. Effectively communicates objective assessments of the likelihood of success of these regulatory strategies. Provides strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs and/or oversight of marketed product support, while maintaining full compliance with applicable regulatory requirements.
- Provide regulatory expertise for multiple projects and/or one highly complex project for assigned development project and / or marketed product(s) of responsibility.
- Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to project areas and/ or region of responsibility enabling proactive approach and planning to future business requirements.
- Primary Japanese regulatory authorities contact for project(s)/products of responsibility or can delegate to vendor with oversight. Informs the business. Manages interactions with Japanese regulatory authorities for specific product(s).
- Leads the regulatory working team for Japan and represents as needed at project team and ensures regional regulatory lifecycle management strategy and submission planning written and executed according to plan – or oversees if delegated and/ or vendor.
- Partner with the Japan market access and to understand market access and reimbursement topics and support opportunities to drive consolidated inputs into Japan product development plans.
- For the project(s)/product(s) of responsibility, collaborates with Global and Regional colleagues for the authoring of global regulatory strategies and ensures own critical deliverables as agreed within the global regulatory strategy and planning.
- Where responsibility includes a marketed product, provides oversight to ensure regulatory compliance, including oversight of the product related data in the registration database.
- Accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within Japanese responsibility.
- Identifies relevant Japanese regulatory requirements and provides regulatory guidance, and expertise to internal team on the assigned project(s) of responsibility. Authors and reviews Japan regulatory strategies as well as executes day-to-day activities for projects or may delegates to vendor with oversight.
- Usually includes supervision of vendor activities.
- Leads and manages meetings and / or interactions with regulatory authorities and agency meetings; or delegates and oversees direct reports and / or vendor; negotiates on behalf of project team as necessary.
- Regulatory reviewer in due diligence for licensing opportunities, development and /or marketed product opportunities.
- Proactively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to achieve Takeda strategic goals and objectives.
- Identifies regulatory requirements and trends across area(s) of responsibility, and provides regulatory guidance, and expertise to Japan development team and/or higher governance bodies in these areas, as requested.
- Identifies and proposes solutions to the management of resource gaps for areas of responsibility.
- Presents to senior management as requested.
- Labeling management for TA products.
Develop labeling strategy and draft labeling for NDA/PCA submissions considering characteristics of the disease/compounds, trends in the industry, pricing/reimbursement system, PTRB etc.
Maintain JPI including revisions and its management, necessary regulatory procedures and coordination of relevant functions. etc.
- Product Information (NS&MP G only)
Gather and Provide regulatory information for the existing products in response to queries from internal or external customers.
Support Regulatory Review for promotional materials and publications
- MSc preferred
- Basic knowledge of regulations and medical in the assigned TA.
- People management experiences is not mandatory
- Overseas work experience is not mandatory
- Fluent English language skill is desired in oral and written commutation
(e.g. TOEIC: 730 points).
勤務時間：本社（大阪市中央区・東京都中央区）9:00～17:30 、工場（山口県光市・大阪市淀川区）8:00～16:45 、研究所（神奈川県藤沢市）9:00～17:45
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