?Animal Health?Director Product Development & Regulatory Affairs Chiyoda City
Chiyoda City TOKYO
?Animal Health?Director Product Development & Regulatory Affairs Chiyoda City Job Description
The Director of the Product Development and Regulatory Affairs (PDRA) team is responsible for the overall management of product development and regulatory activities of Animal Health in Japan. The position requires a combination of scientific knowledge, understanding of regulatory requirements, strategic thinking, and team leadership to ensure timely registration of new products and maintenance of existing licenses for the Japanese market. The PDRA Director will ensure compliance with internal and external requirements, including pharmacovigilance obligations.
The PDRA Director will partner with local, regional and global stakeholders from Research and Development, Regulatory Affairs, and Sales Business Units to achieve successful product registrations in Japan. He/she will ensure that the PDRA team develops and successfully executes project plans for timely product registrations. He/she will work with the PDRA team and Finance to plan and track... the department budget expenditures.
The PDRA Director will motivate and encourage the PDRA Team to perform successfully and will mentor and coach team members to oversee their personal development in the organization.
Reporting lines: The PDRA Director reports directly to the Executive Director, Research (located overseas) The PDRA Director has a dotted reporting line to the Commercial General Manager Japan The PDRA Director manages a team of 12-15 colleagues divided between a Product Development group and a Regulatory Affairs group
PRIMARY ACTIVITIES: 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. Ensure that the PDRA team develops local regulatory strategies to minimize time to market in Japan, and expedites product development by leveraging global data. Drive execution of project plans by the PDRA team according to agreed product profiles, budgets and schedules. Provide regular updates to management and stakeholders to discuss progress and obstacles in the project portfolio. Liaise with Sales BU in the identification of market potential/requirements for new vaccines, vaccine improvements and pharmaceutical products Oversee the PDRA teams collaborations with Contract Research Organizations (CROs). Ensure contract management and quality oversight of CROs. Ensure compliance of organizational structures, internal processes, operational activities & reporting including national and overseas pharmacovigilance requirements in line with the respective pharmaceutical law guidelines Oversee the scientific quality of work within the unit to maintain and enhance reputation for excellence Provide advice on research issues, problems and trends having significant impact on divisions achievement of short and long-term goals 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
Merck Leadership Standards applicable to the role include: 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.
Education Veterinarian or PhD in Biological or Animal Sciences preferable.
Experience Minimum 7 years of relevant experience in a regulated industry, preferably healthcare, most preferably in the field of veterinary vaccines or pharmaceuticals. Knowledge of Japanese Regulatory System Experience leading teams and developing/coaching people to maximize people/team capability. Working in a matrix environment with multiple stakeholders at local and global levels. Experience in planning and drafting budgets for approval.
Skills, Knowledge and Competencies Language Japanese (fluent), English (professional level verbal and writing) Highly developed skills in negotiating, influencing, leadership and staff motivation. Excellent communication and organizational skills. Ability to work well with other departments in a multicultural team setting and matrix organization Familiarity with animal diseases and animal husbandry techniques and ability to understand our product users including farmers and veterinarians. Ability to make sound decisions on a day to day basis concerning product development and regulatory affairs. Knowledge of Microsoft Office
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Employee Status: Regular
Flexible Work Arrangements:
Valid Driving License:
Number of Openings: 1
Requisition ID:R54536 Chiyoda City Tokyo Japan
?Animal Health?Director Product Development & Regulatory Affairs Chiyoda City MSD Chiyoda City