Regulatory Affairs Manager

서울시
정규직
풀타임

9일 전
쉽게 지원하기

At Medison, we are not just a pharmaceutical company - we are a purpose-driven organisation dedicated to transforming the lives of patients with rare and severe diseases. With a bold global footprint and a fast-growing pipeline, our mission is clear: to ensure no patient is left behind, no matter where they live.As we expand our presence in South Korea, we are looking for a Regulatory Affairs Manager to join our passionate team and help shape the future of rare disease treatment in the region.Why Join Us?

Make a Meaningful Impact: Be at the forefront of bringing life-changing therapies to Korean patients.
Global Collaboration: Work closely with regional and global experts across medical, regulatory, and commercial functions.
Agile Environment: Join a nimble, fast-growing biotech that values innovation, speed, and trust.

Responsibilities:Regulatory Affairs

Serve as the local authority on MFDS regulations and global regulatory trends.
Develop and execute regulatory strategies that support product registration, lifecycle management, and commercial success.
Prepare and manage all health authority submissions and maintain product licenses.
Partner cross-functionally to ensure timely, compliant product launches and communications.
Engage and manage third-party vendors supporting regulatory operations.

City:
Seoul

Bachelor’s degree in Pharmacy or related field (licensed pharmacist preferred).
5+ years of experience in Regulatory Affairs.
5+ years of experience in Rx pharmaceutical regulatory affairs in Korea (orphan drug or BLA experience is a plus).
Familiarity with global GxP standards and vendor management.
Strong project leadership, communication, and problem-solving skills.
Business-level English proficiency (written and spoken).
A collaborative mindset, with a hands-on approach and the ability to thrive in a matrixed, high-growth environment.

Ready to Help Patients Who Need You Most?This is more than a job - it’s a mission. If you’re looking to make a difference, take ownership, and grow with a global company that’s deeply committed to the Korean market, we’d love to meet you.Join us and help change the standard of care for patients with rare and devastating diseases in Korea.

Medison Pharma