Join Recordati Korea in Driving Growth

Recordati is a dynamic growing company focused on unlocking the full potential of life. We are constantly looking for highly talent individuals across our business units to help deliver our purpose.

Located in Seoul, Recordati Korea serves as the regional office for all of Asia excluding China and Japan, specializing in rare diseases. We are experiencing rapid expansion, dedicated to swiftly bringing new medications to Korea and the broader Asian market, offering hope to patients with rare diseases. We are seeking proactive, collaborative business professionals to join us in leading our organization forward and growing together.

Recordati is committed to respecting diversity and inclusion. All applicants will be evaluated fairly, regardless of gender, age, background, education, disability, or beliefs.

Position: Regulatory Affairs Specialist 
Reports To: Regulatory Affairs Lead
Areas to look after: Korea
Location: Seoul

Employment Type: Fixed-term (1 year) contract to cover maternity/parental leave 
Period: mid-July 2026 to mid-July 2027 (subject to change depending on leave schedule)

Reporting to the Regulatory Affairs Lead, the Regulatory Affairs Specialist supports hands‑on regulatory activities for assigned products in Korea.
The role focuses on MFDS submissions, post‑approval lifecycle management, and regulatory compliance activities, in accordance with local requirements and established internal processes.
 
Major Responsibilities

1) Regulatory Lifecycle Management

• Prepare, compile, and file MFDS submissions for approved products, including post‑approval variations, in compliance with local regulations and internal SOPs and support post‑approval follow‑up activities as required.
• Perform regulatory change impact assessments for proposed changes and support the development of appropriate MFDS submission strategies and timelines, in collaboration with the Regulatory Affairs Lead.

2) Regulatory Compliance Review

• Support regulatory management of labeling and artwork changes to ensure consistency with approved product information and local requirements.
• Review promotional materials from a regulatory compliance perspective (alignment with approved claims and local regulations), in collaboration with cross‑functional teams (e.g. Medical, Marketing), as applicable.

3) Coordination & Authority Interaction

• Coordinate day‑to‑day regulatory interactions with MFDS (e.g. submission logistics, clarification requests), under the guidance of the Regulatory Affairs Lead.
• Liaise with global and regional regulatory teams to align documentation requirements, timelines, and follow‑up actions for assigned activities.

Qualification Required  

Professional Qualifications and Competencies

• Bachelor's degree in a scientific field required
• At least 1 year of experience in Regulatory Affairs within the pharmaceutical industry
• Hands‑on experience with MFDS submissions and post‑approval change management 
• Business‑level English communication skills

Personal Competencies 

• Reliable and detail‑oriented, with strong accountability for quality and completeness of assigned deliverables
• Able to manage assigned priorities and meet regulatory timelines within a defined scope, with appropriate guidance 
• Proactive in identifying issues early, escalating appropriately, and driving tasks to closure 
• Demonstrates flexibility and adaptability when working in a small team environment
• Communicates clearly and effectively with cross‑functional and regional stakeholders