Regional Regulatory Strategy Lead

Job Title: Regional Regulatory Strategist

• Developing and implementing regional regulatory strategies and processes to support the timely registration of new products, major changes, and life cycle management.
• Recommending strategies to business units on ways to resolve issues related to regulatory premarket activities and promoting strong partnerships to drive implementation and resolution.
• Representing the company in local or regional standards committees, industry associations, national competent authorities, influencing future regulations and standards, and deploying them within the organization.
• Proactively identifying market opportunities by influencing product registration, prioritizing product registration, mitigating potential regulatory approval risks based on regulations, standards, country-specific issues, or other unique characteristics.
• Effectively communicating between global and local regulatory affairs teams to ensure the implementation of all strategic plans.

• Coordinating with Regulatory Affairs in manufacturing units and CRAO and regulatory affairs teams in countries under scope to ensure optimal, efficient, and compliant registration and QA reporting.
• Leading and driving RA/QA activities in accordance with local and international requirements to ensure Terumo products are registered on time or life cycle management in the markets are in scope of responsibility, and post-marketing surveillance risks are minimized.
• Responsible for regulatory monitoring and analysis of new or updated local legislation and assuring timely registration in the local market (country).
• Creating a regulatory plan and labelling plan (when needed) to ensure consistency and guidance to market introduction projects.
• Improving efficiency of entity RA teams to create a cogent process of documents/data management/storage and/or document flow which is easy and efficient for access to relevant stakeholders.
• Working with in-country RA teams to ensure product compliance by executing the annual regulatory plan and reviewing all relevant compliance evidence.
• Consulting with product and solutions teams to ensure timely, effective, and efficient transition to new requirements.
• Managing distributors and ensuring compliance on RA&QA matters.
• Encouraging creation and use of automated/visual dashboards and scorecards for as many business and function process tracks.

• Acting as a mentor and supporter to in-country regulatory affairs team members.
• Sharing knowledge and guiding and mentoring others about regulatory best practices and registration standards for regulatory approvals and post-market needs.
• Working with HR to actively plan, develop, and assess learning needs of key associates, with specific focus on current and future business needs of the organization.
• Building a personal network within the relevant talent community and taking personal accountability in attracting, developing, mentoring, retaining, and growing best regulatory affairs talent in the region.
• Providing TAP/RA associates with educational programs about RA knowledge enhancement, Terumo group products, and BU marketing strategy.
• Organizing yearly Asia RA meeting for development and planning of RA yearly strategy plans.

• Demonstrating Gemba (visiting field or floor), Gembutsu (seeing actual products in R&D, production, and use), and Genjitsu (facing reality) are fundamental business traits.

• Working on establishing a close-knit, collaborative, and supportive team within the region. Understanding BUs operations and priorities, working cooperatively with others across the organization to achieve shared objectives to support business requirements.
• Being a quality champion by viewing each issue from a business perspective.