17707 Head of RA, R&D
・Via the global matrix structure, provide regulatory input to the global clinical development plan for the pipeline products
・Provide necessary Japan specific inputs to RA HQ in a timely manner to proceed Japan RA activities smoothly
・Recognize the company’s (both global and Japan) business needs and provide constructive ideas to move projects forward
・Develop and maintain efficient communication channel with RA Head/Asia Pacific RA to be aligned with the Global/Asia regulatory strategies
・Lead and manage the local project team liaising with other cross-functional representatives, counterparts in the headquarter, and other stakeholders
・Responsible for interactions with PMDA/MHLW
・Lead all necessary preparation activities of J-NDA filing
・Supervise and/or author the documents generated for PMDA meetings and J-NDAs
・Supervise the quality assurance manager and the safety manager as General Marketing Compliance Officer.
・Ensure the regulatory quality compliance in the co-promotion setting
・Liaise with partners for regulatory aspects of the company’s projects
・Aim for a good collaborative working environment in the organization
・Ph.D is preferable, but not mandatory. Alternatively, a Master’s degree in natural science
・Minimum of 10 years of proven professional experience at a pharmaceutical company or CRO, preferably in leadership position(s) in regulatory Affairs.
・Experience with acting as regulatory expert/lead in successful interactions with PMDA, preferably in psychiatry or neurology
・Experience with acting as regulatory expert/lead in successful J-NDA and approval, preferably in psychiatry or neurology
・Experience in Regulatory Affairs of different drug modalities, e.g. small molecules, antibodies etc.
・Experience with operating in cross-functional international environment in matrix-driven
project organization and/or partnerships, leading via others
・Able to develop respected relationships with health authorities, i.e., PMDA, MHLW
・Able to develop respected relationships with pharmaceutical industry via EFPIA, Pharma, JPMA, etc.
・Strong leadership and collaboration skills
・Thought leadership and source of inspiration for direct reports and co-workers
・Scientific thinking, curiosity, willingness to go into details and challenge status quo
・Customer-centric approach, being able to understand customer needs and deliver value adding outcomes with high quality, on time and in a resource efficient manner
・Proactivity proposing creative, practical and scientifically solid solutions for complex problems
・Excellent communication and presentation skills in both verbal and written English with the ability to translate complex data into relevant and compelling information for internal and external customers