Regulatory Affairs

Job description

The role will be responsible for achieving corporate objectives and effectively ensuring that agreed strategies are implemented.

Accountable for all regional and local regulations for the statutory compliance of all regulatory and QA affairs activities of the Company.

A key requirement will be to balance internal hands-on execution priorities with regional strategic alignment, and at the same time, be able to navigate the current complex policy environment.

Contribute with regulatory skills to the innovation of products and services focusing on improving patient's outcome.

The role requires strong understanding of the regional business environment, work in collaboration with regulatory/ Q&R team in the markets, strong interaction with corporate/manufacturing RA teams on Regulatory Affairs matters.

To represent Terumo and participate in industry associations (e.g. APACMed, MTAA, etc.) to create Terumo voice of advocacy.

Key Functions/Responsibilities

Strategic Planning:
• Developing and implementing regional regulatory strategies and processes to support the timely registration of new products, major changes and life cycle management.
• Recommend strategies to the business units on ways to resolve issues related to regulatory premarket activities and promote strong partnerships to drive
implementation and resolution.
• Represent Terumo in local or regional standards committees, industry associations, national competent authorities influencing future regulations and standards and deploy them in the organization
• Proactively identify market opportunities by influencing product registration, prioritizing product registration, mitigate potential regulatory approval risks based
on regulations, standards, country-specific issues or other unique characteristics
• Effectively communication between global, TAP RA to ensure implementation of
all strategic plans.

Operation Efficiency:

• Coordinate with Regulatory Affairs in the manufacturing units and CRAO and
regulatory affairs teams in the countries under the scope to ensure optimal,
efficient and compliant registration and QA reporting.
• Lead and drive 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 minimised.
• Responsible for Regulatory monitoring and analysis of new or updated local
legislation and for assuring in-time registration in the local market (country).
• Create a regulatory plan and a labelling plan (when needed) to ensure
consistency and guidance to the market introduction projects.
• Improve 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.
• Work with in-country RA teams to ensure product compliance by executing the
annual regulatory plan and reviewing all relevant compliance evidence.
• Consult with product and solutions teams to ensure timely, effective and efficient
transition to new requirements.
• Management of distributors and ensure compliance on RA&QA matters
• Encourage creation and use of automated / visual dashboards and scorecards
for as many business and function process tracks

Talent Development and Management:

• Act as a mentor and supporter to the in-country regulatory affairs team members.
• Share knowledge and guide and mentor others about regulatory best practices
and registration standards for regulatory approvals and post-market needs.
• Work 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
• Build a personal network within the relevant talent community and take personal
accountability in attracting, developing, mentoring, retaining and growing best
regulatory affairs talent in the region

• Provide TAP/RA associates with educational programs about RA knowledge enhancement, Terumo group products, and BU marketing strategy.
• Organise yearly Asia RA meeting for development and planning of RA yearly
strategy plans.

Deliver through a hands-on management style:

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

it is important for this role to demonstrate this.
• Always remain accessible and practice open management.

Support teams in
execution of product requirements and registration.

Champion of Terumo culture:

• Work on establishing a close-knit, collaborative and supportive team within the
region.

Understand BUs operations and priorities, work cooperatively with others
across the organization to achieve shared objectives to support business
requirements.
• Be a quality champion by viewing each issue from a Gemba perspective in order
to find the optimal solution.

Pursue excellence in product quality, from product
supply to customer care.
• Focus efforts on continuous improvement; has a knack for identifying and seizing
opportunities for synergy and integration.

Figure out the process necessary to get
things done

Education & Experience:

• Graduate or Post Graduate degree/s.

(Medical / biomedical background)
• Working experience in Regulatory Affairs Medical Device (class 1, 2 and 3) is a must

• A minimum of 5 years working experience in Regulatory Affairs in APAC Team management experience.
• Proficient in Japanese and ability to transcribe dossier from Japanese to English

Key Technical/Functional Competencies:

• High level of regulatory concepts and standards
• Knowledge of product development and clinical investigation
• Highly regarded personal work ethics and character
• Talent Management.

People skills extraordinaire, people empathy & compassion
• Open, inspiring and high quality communication style.


• Willingness to ask for help
• Relevant in-country & sectoral / sub-sectoral understanding (an exception can be made for a highly talented candidate)

Required Skill Profession

Other General