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【R&D】Japan Regulatory Lead, R&D

Plats Kita-ku, Ōsaka-fu, Japan Jobb-id R-059408 Datum inlagd 11/14/2019

【職務内容 / Job Description

• Japan Regulatory Lead (JRL) is responsible for planning and execution of Japan regulatory strategy of the assigned products/projects by
➢ Providing strategic regulatory expertise for optimum market access of the products in Japan as a member of Japan project team and Global Regulatory Strategy Team(GRST)
➢ Leading communication of the global regulatory strategy and its implication to Japan so that the context of regulatory input are properly understood by the governance bodies in GMeds, iMeds and MedI for their quality decisions through communication with GRST/Global regulatory execution team (GRET).
➢ Preparing, updating, and implementing regulatory operational plans to deliver regulatory outcomes of the assigned products/projects.
➢ Managing quality regulatory deliverables of the assigned products/projects throughout the product’s lifecycle.

• JRL will also contribute to regulatory policy shaping within the TA by working closely with TA RAD and Regulatory Policy and Intelligence Department
• JRL will work flexibly within and across the Therapeutic Areas to provide broad operational and/or strategic support to ensure regulatory deliverables

Responsibilities (for all bands):

• 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.

【応募資格(経験、資格等)/ Qualification (Experience & Skill etc)

◆◆学歴 / Education◆◆

• Bachelor’s Degree in Science or related discipline

◆◆経験 / Experience◆◆

<必須 / Mandatory

(for all bands)

  • 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

(for band E)

  • Demonstrated experience in regulatory drug/device development, approval andlaunch.
  • Proven leadership and program management experience.
  • Ability to think strategically and critically evaluate risks to regulatory activities.
  • Successful contribution to a major regulatory approval at a regional level.

<歓迎 / Nice to have

  • Getting drug/device approvals and supporting launch activities, such as a price negotiation, as a leading person
  • Drug development and regulatory affairs experience in outside of Japan
  • Working with external bodies, such as co-development companies and key opinion leaders, as a leading person.
  • Line management

◆◆能力 / Skill-set◆◆

(for all bands)

  • Project management skill
  • Customer focused
  • Communication and assertiveness
  • Business English (Speaking level 6 or above)
  • Understanding of the importance of Continuous Improvement
  • Knowledge Sharing
  • Team working
  • Ethics – overriding commitment to integrity and high standards in self

(for band E)

  • Strategic Influencing – through well thought out rationale and effective communication skills, able to influence key decisions.
  • Communication skills – knows when and how to communicate, using strong interpersonal skills and written communications when appropriate
  • Business English (Speaking level 6 or above, Achieve common understanding at the context level with customers)
  • Results Focused – ability to overcome obstacles and achieve key outcomes
  • Cultural Awareness – able to work successfully in a multi-cultural environment
  • Analytical Thinking - Logically breaking situations or issues down into their essential elements; carrying out diagnosis and developing solutions.
  • Ability to gain commitment – effectively uses interpersonal abilities to build relationships and gain acceptance of ideas
  • Builds effective partnerships – identified opportunities and takes actions to build effective relationships within team and with other areas
  • Ethics – overriding commitment to integrity and high standards in self and others

Feeder roles :

  • Japan Regulatory Associate
  • Japan Regulatory Policy & Intelligence Staff, Leader
  • Japan Regulatory Compliance Staff, Leader
  • Regulatory Compliance & Operation Staff, Leader
  • Japan Associate Director Clinical Development
  • Japan Clinical Development Manager
  • Clinical Research Scientist
  • Safety Science Staff, Group Manager
  • Project Manager, Project Strategy & Management
  • The person who meets the requirements above

Measures of Success :

• The context of regulatory input, including risks, mitigations and setting right expectation of Regulatory Probability of Success (POS), is properly understood by the internal governance bodies for their quality decisions and by the internal stakeholders for the engagement.
• Optimum regulatory interface to MHLW/PMDA is provided for optimum market access of the assigned products/projects
• The learner/player behaviors are demonstrated

Reporting Relationship :

  • Report to TA Regulatory Affairs Director
  • Direct reports : None

◆◆勤務地 / Work Location◆◆

  • Osaka or Tokyo

◆◆キャリアレベル / Career Level◆◆

  • D or E (will be varied based on the candidate's experience)

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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