Regional Regulatory Strategist

Job Description

The role is responsible for achieving corporate objectives and ensuring that agreed strategies are implemented. It involves being accountable for all regional and local regulations to guarantee the statutory compliance of regulatory and quality assurance activities.

A key requirement is to balance internal execution priorities with regional strategic alignment, while navigating the current complex policy environment.

Contribute to the innovation of products and services focusing on improving patient outcomes. The role requires a strong understanding of the regional business environment and collaboration with regulatory/quality teams in the markets.

Represent the company in industry associations to create a voice of advocacy.

Key Functions/Responsibilities

• 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.

Operation Efficiency

• 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.

Talent Development and Management

• 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.

Deliver through a Hands-on Management Style:

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

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