RA specialist

Job Description

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Job Description

Job Title: RA specialist
Location: South Korea, Seoul

About the role:

• Comprehend priorities and objectives of Takeda and commit to working towards it
• Develop working relationships with GRA, GEMRA 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 Head of Regulatory Affairs / Regulatory Affairs Manager
• Complete relevant reports within designated timeframes
• Handle multiple priorities to achieve long and short-term goals

How you will contribute:

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.

What you bring to Takeda:

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

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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