該当求人数 1 件中1～1件を表示中
Japan Regulatory Lead, R&D
- Create regulatory strategies of the assigned products to make sure they are consistent with the business objectives, including identification of the regulatory risks, mitigations of the risks, strategy for HA interactions and engagement of key stakeholders properly
・Deliver the Japan regulatory component of the product’s development plan, regulatory strategy document (RSD), TPP, TPC, LIST, Core Data Sheet, Investment Decision (ID) delivery including assessment of the approvability of the program together with risk mitigations.
・Deliver regulatory outcomes, such as JNDA/sJNDA approval, successful HA consultation, CTN submission, re-examination approval and right labelling negotiation after launch etc.
・Provide leadership for JNDA/sJNDA submission and approval as a JNDA/sJNDA team lead
・Provide leadership for PMDA consultation
・Provide PMDA interface and regulatory input to study delivery team to ensure regulatory compliance for the clinical study as a member of JSDT
・Provide leadership to ensure regulatory compliance for post marketing regulatory activities as leader of Japan maintenance team(JMT), including reexamination submission and approval, PSUR submission and labelling negotiation etc.
・Provide right interface to Health Authority (HA).
・ Make sure the regulatory knowledge is properly recorded and maintained according to the internal process
・Contribute the regulatory policy work within the TA portfolio in line with the agreed direction as a company to facilitate the regulatory strategy planning and execution
・Monitor changes in the regulatory environment, both general and specific to the therapeutic area and support and advise the project team accordingly.
・Share best practices within regulatory affairs and other functions.
・ Participate in regulatory line and therapy area initiatives leading to processimprovement and development of specialized expertise as needed.
・Ensure that own work is performed in accordance with appropriate SHE and Compliance standards.
Additional Responsibilities (for band E):
・Lead and coach the other JRLs/JRAs working on a product/project to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality. And identify any potential risks/opportunities along with possible contingencies to ensure the earliest appropriate submission and earliest possible approval of key deliverables with advantageous labelling.
・ Define innovative strategies to partner and interact with regulatory authorities to optimize the predictability of the regulatory outcome for the specific project(s) and to provide the regulatory platform for optimal market access.
・Monitor, interpret and validate current and changing regulatory legislation and share potential impact with relevant functions about these activities may have on the product development program. And provide training within the JRL skill group and/or relevant other functions.
・Proactively participate in skill-development, coaching, and performance feedback of the other JRLs/JRAs working on the product/project.
・Support or lead product related issue management.
・ Provide regulatory leadership as needed in the evaluation of product in licensing / due diligence, product divestment and product withdrawal.
・Delivers Non-product related project assignments supporting the business, e.g., representation or leadership on cross-functional task forces.
・Relevant regulatory experience or experience elsewhere in Pharmaceutical industry
・Cross-functional project team experience
・Thorough knowledge of the drug development process
・Written and verbal communication skills
・Scientific knowledge sufficient to understand all aspects of regulatory issues