※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
- Lead the PDRA organization to ensure timely approval and maintenance of biological and pharmaceutical veterinary products in Japan in compliance with the general pharmaceutical guidelines and with local laws
- Develop local regulatory strategy to minimize time to market and identify opportunities to expedite product development by leveraging global data
- Oversee the scientific quality of work within the unit to maintain and enhance reputation for excellence
- Provide expert advice on research issues, problems and trends having significant impact on division's achievement of short and long-term goals
- Monitor and evaluate disease situation and competitive R&D activities in Japan
- Cooperate with Global R&D to evaluate and select a) potential development products from existing R&D portfolio b) Japan specific development products based on combinations of standard vaccines as well as new vaccines for Japan specific pathogens
- Liaise with Sales BU in the identification of market potential/requirements for new vaccines, vaccine improvements and pharmaceutical products
- Seek approval of new projects in line with global R&D Governance for both pharmaceuticals and biologicals
- Develop and maintain strong relationship with Global R&D and Regulatory Affairs organization to ensure local requirements are included into global development program
- Organize local development activities in collaboration with CRO's. Ensure contract management and quality oversight of CRO's
- Ensure management of projects and other activities according to agreed targets, budgets and schedules, review periodically and discuss progress/obstacles with management
- Ensure compliance of organizational structures, internal processes, operational activities & reporting including national and overseas pharmacovigilance requirements in line with the respective pharmaceutical law guidelines
- Help identify new business development opportunities and support development and management of cooperation / alliances with key business partners
- Provide scientific expertise and technical support to the Manufacturing & Quality organization as needed
- Ensure and optimize the performance of PDRA colleagues by coaching, motivating, training and evaluating them properly in line with global and local development program, including setting and reviewing individual yearly objectives and development plans
- Regularly reinforce colleagues' commitment to ensure full compliance with all company policies as well as applicable government regulations
- Represent our company in local industry association as required
- Veterinarian or PhD in Biological or Animal Sciences
- Minimum 10 years of relevant management experience in pharmaceutical industry, preferably in the field of veterinary vaccines
- Understanding of immunology, disease epidemiology and animal husbandry techniques
- Knowledge of Japanese Regulatory System
- Leading team and developing/coaching people to maximize people/team capability.
- Language - Japanese (fluent), English (business level - verbal and writing)
- Working in the matrix environment where need to work for global and local. (preferred)
- Make Rapid, Disciplined Decisions - Make timely decisions at the right level with the right data, and support them once made.
- Build Talent - Build diverse talent with the capabilities necessary to succeed in our markets; inspire, reward and develop to ensure individuals reach their potential; make tough calls when necessary.
- Act with Courage & Candor - Speak openly, honestly and with conviction: have the courage to take appropriate risks and make difficult decisions.
- Demonstrate Ethics & Integrity - Adhere to the highest standards of trustworthy and ethical behavior in all interactions and hold others to the same standards; comply with all laws, policies and regulations; identify and address ethical issues without hesitation.
- Foster Collaboration - Actively listen and seek to understand differing perspectives; work together to achieve the common goals of the new Merck.
- Focus on Customers & Animal Health outcomes for the benefit of all stakeholders - Focus the entire organization on delivering value for customers, including the greater community by understanding and meeting their needs.
- Drive Results - Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results.
※Experiences and skills will be considered
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.