Regulatory Affairs Specialist(1년 계약직) [South Korea]

 

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Job Description

Overall

• 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 timeframesHandle 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

Qualifications:

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

Experience:

• A minimum of 3 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.
• Microsoft Office Skills (in particular, MS Word, MS Excel, MS PowerPoint)
• The ability to work flexible hours to accommodate early morning/evening meetings/ teleconferences.

Locations

Seoul, Korea

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time

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