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Regulatory Affairs Specialist - 1 year

ID:  2443
Date of Posting:  Apr 7, 2026
Business Area:  Regulatory Affairs
Job Type:  Direct Employee
On site / Remote / Hybrid:  On Site
Hub Office: 

Seoul, KR

Territory: 
Full-Time or Part-Time:  Full Time
Seniority:  Entry level

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn.

We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.

At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.

This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.

Recordati. Unlocking the full potential of life.

Job Purpose

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.

Key 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.

Required Education

  • Bachelor’s degree in a scientific field required

Required Skills and Experience

  • 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

Required Behaviours and 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

At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.

We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.

If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.

Apply now »