Regulatory Strategy Manager is expeced to leverage expertise in regulatory affairs in Japan. leads the formulation and promotion of regulatory
strategies for developing projects, regulatory applications, and negotiations with authorities based on own depth and breadth of expertise.
Through collaboration with global teams and cross-functions, he / she aims to accelerate the development of its products and deliver Viatris
products to patients as soon as possible.

・Development and promotion of regulatory strategies based on Japan’s regulatory requirements
Build regulatory strategies and solve complex issues on his/her own. Coordinate cross-function and global to lead decision-making.

・Lead in NDA submission and response to authorities
Lead the development of policies for the preparation of CTDs and inquiry response materials, conduct PMDA consultations and NDA submissions, and ensure regulatory compliance and adherence to internal standards as the regulatory lead. Be responsible for building good relationships with authorities.

・Managing the execution of regulatory strategies
Based on the departmental strategy, manage the execution of regulatory affairs strategies according to the development stage and indication additions. Understand risks, resources, and timelines to identify and address challenges early.

・Cross-functional Collaboration
Collaborate with clinical development, CMC, PV, quality, medical, etc., to promote cross-functional problem solving. Represent your team in discussions and build consensus.

・Coaching with junior members of a team
To foster a regulatory strategist and build up the capability of the team, share the knowledge and experience, and coach junior members