Offer summary

Qualifications:

Bachelor’s degree in Pharmacy or related field, Pharmacist license preferred., 7–13 years of experience in Regulatory Affairs and Pharmacovigilance., Minimum 5 years of experience with prescription medicines, including orphan drugs or BLAs., Strong knowledge of MFDS regulations, GxP standards, and PV systems..

Key responsibilities:

Serve as the local expert on regulatory affairs and maintain knowledge of MFDS regulations.

Develop and manage documentation for health authority submissions and product lifecycle management.

Establish and maintain a compliant pharmacovigilance system, report safety data, and manage risk plans.

Collaborate with internal teams and external partners to ensure regulatory and PV compliance.

Job description

Description

Medison is a distinctive global pharmaceutical company with a clear mission: to bring groundbreaking therapies to patients suffering from rare and severe diseases across international markets. We believe that all patients, regardless of location, deserve access to the best available treatments—and we are here to make that happen.

As we continue our global expansion, we are looking for passionate, purpose-driven individuals who are eager to make a meaningful impact. We are patient-centric, innovative, agile, and always forward-thinking.

Join our growing team in Korea!

Responsibilities

Regulatory Affairs

Serve as the local expert on regulatory affairs, maintaining up-to-date knowledge of MFDS regulations and industry trends.
Provide strategic regulatory guidance and support cross-functional decision-making.
Develop and manage documentation and processes for health authority submissions.
Maintain product licenses and oversee the full product lifecycle.
Develop and implement regulatory strategies aligned with business goals.
Identify, qualify, and manage third-party vendors for regulatory activities.
Ensure compliance of all communications and promotional materials with regulatory standards.
Support internal teams (e.g., Business Development) with regulatory insights.
Ensure adherence to Medison SOPs and partner procedures.

Pharmacovigilance

Act as the local subject matter expert for pharmacovigilance (PV).
Establish and maintain a compliant local PV system in alignment with global and local requirements.
Collect, manage, and report safety data to the MFDS.
Collaborate with partners and vendors to ensure effective PV operations.
Manage local Risk Management Plans (RMPs) and additional risk minimization measures.
Prepare and submit local RMP implementation reports and PSURs.
Oversee safety information related to Post-Marketing Surveillance (PMS).
Conduct PV training for employees and vendors.
Draft and manage Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs).
Ensure inspection readiness and oversee PV vendor services.
Support APAC ICSR reporting to health authorities or global teams.

General

Demonstrate strong communication, collaboration, and leadership across internal and external stakeholders.
Proficient in both written and spoken English.

Requirements

Bachelor’s degree in Pharmacy or a related field (Pharmacist license preferred).
7–13 years of experience in Regulatory Affairs and Pharmacovigilance.
Minimum 5 years of experience in prescription medicine regulatory affairs; experience with orphan drugs or BLAs is a plus.
Minimum 5 years of experience in PV, including direct interaction with local health authorities.
Experience managing vendors and working with international teams is advantageous.
Strong knowledge of MFDS regulations, international GxP standards, and evolving regulatory landscapes.
Familiarity with PV system development and maintenance.
Collaborative team player with strong interpersonal and influencing skills.
Comfortable working in a dynamic, fast-paced, matrixed organization.

Required profile