Regulatory Affairs and Pharmacovigilance Manager
Regulatory Affairs and Pharmacovigilance Manager
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 & Pharmacovigilance (RA/PV) 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.
Pharmacovigilance
- Support local PV system setup and oversight in alignment with MFDS and global standards.
- Collect assess and report safety data - ensuring timely and compliant submissions.
- Manage local Risk Management Plans (RMPs) Post-Marketing Surveillance (PMS) and periodic safety reports.
- Build strong partnerships with vendors and internal stakeholders to support safety operations.
- Prepare for inspections and ensure audit-readiness at all times.
Requirements :
- Bachelor s degree in Pharmacy or related field (licensed pharmacist preferred).
- 7 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).
- PV experience including local authority engagement and safety system leadership (strong advantage).
- 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.
Remote Work :
Yes
Employment Type :
Full-time
Employment Type
Remote
