Regulatory Affairs Specialist

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Job Description

Job Title:  Regulatory Affairs Specialist

Location:  Seoul, South Korea

About the role: 

The Regulatory Affairs Department plays a pivotal role in the various stages of the life cycle of Takeda products. As a key member of the department:

• You will support the Head of Regulatory Affairs/ Regulatory Manager to ensure regulatory plans are implemented

• You will undertake regulatory activities with both internal and external stakeholders.

• You will also build and maintain effective working relationships and professional conduct with internal and external stakeholders while continuing to promote the high quality and ethical image of Takeda

How you will contribute: 

• Comprehend priorities and objectives of Takeda and commit to working towards it

• Develop working relationships with GRA, EMRA, APAC RA and the local regulatory authority to ensure optimal stakeholder management and LOC support

• Co-operate with local functions to support development and implementation of regulatory plans that support commercial goals and product launch excellence

• Develop and maintain current information and comprehensive knowledge on designated product portfolio

• Coordinate and contribute to special project assignments as determined by the Regulatory Affairs Director / Manager

• Complete relevant reports within designated timeframes

• Handle multiple priorities to achieve long and short-term goals

Regulatory submissions

• File assigned new drug and variations applications in a timely manner in accordance with agreed regulatory plan

• Ensure effective product life cycle management and file label updates in accordance with global/local SOPs.

Regulatory compliance

• Ensure continued regulatory compliance through maintenance of registrations by timely submission of post-approval variations and update of regulatory databases

• Review promotional and non-promotional materials for assigned tasks in accordance with regulatory norms and internal compliance rules

Strategic Planning

• Assist in development of regulatory strategies

• Implement regulatory strategies in partnership with internal stakeholders for new product registration and life cycle management

• Monitor and assess impact of new regulations on local procedures and product regulatory strategies

Patient Centricity

• Provide regulatory support for quality assurance, medical affairs and pharmacovigilance activities as expected in Takeda’s global standard operating procedures (SOPs) and policies

People Management

• Create an engaging atmosphere of teamwork and boost overall team morale

Corporate Governance & Quality Management System

• Comprehend and drive Takeda’s operational procedures and policies

• Assist in quality system improvements for the regulatory affairs department

• Execute processes in line with regulatory affairs standard operating procedures and ensure compliance with relevant corporate / department policies.

• Support internal/external audits and implementation of corrective actions, when applicable

• Maintain up-to-date knowledge of Takeda’s standard operating procedures and guidelines

• Ensure timely training of applicable SOPs and retain training records

External Stakeholder Management

• Develop and maintain excellent working relationships with GRA, EMRA, APAC RA and local regulatory authority to ensure optimal stakeholder management and LOC support.

• Participate in Local Regulatory Authority meetings when applicable

• Support Regulatory Affairs Director/ Regulatory Manager on all work related to industry groups

Cross-Functional Collaboration

• Develop and maintain excellent working relationships with other departments including but not limited to commercial, medical affairs, market access, pharmacovigilance, quality assurance, supply chain, compliance, legal and finance

• Support local hospital tender applications, if applicable

• Assist in local authority inspections and internal audits when applicable to the regulatory affairs function

Digital And Ai Capabilities

Takeda has implemented several digital and AI tools that enhance the Regulatory Affairs function. The role is expected to be familiar with and leverage these capabilities if relevant for South Korea:

• Utilize Takeda's in-house GenAI tool to automate and improve the quality and speed of regulatory dossier compilation.

• Engage with internal GenAI-powered chatbot assistant, to streamline Ethics & Compliance procedures and access standardized regulatory information.

• Apply the 'Three Ps' AI strategy framework—Prediction, Personalization, and Productivity—to optimize regulatory workflows and decision-making.

What you bring to Takeda: 

Qualifications:              

• A reputed University degree in Life Sciences / Medical Sciences / Pharmacy or equivalent

Experience:

• A minimum of 1-2 years of experience in the healthcare industry. Experience in regulatory affairs in the pharmaceutical industry would be an advantage 

Skills:

• Performed successfully within a team environment

• A proven ability to achieve goals in a timely manner

• A mind-set of continuous improvement, innovation and be solution-focused with strong problem-solving ability.

• Excellent negotiation, project management, verbal and written communication skills in English.

• The ability to work flexible hours to accommodate early morning/evening meetings/ teleconferences.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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