Regulatory Affairs Specialist- PDx

23 hours ago

South Korea, India GE Healthcare Ltd Full time ₹ 25,00,000 - ₹ 50,00,000 per year
Job Description

Summary

We are seeking a passionate and driven individual to join GE HealthCares Regulatory Affairs (RA) team. The RA Specialist / Sr. RA Specialist will be responsible for obtaining and maintaining product registrations and business licenses in accordance with local regulations, company SOPs, and the strategic direction set by the GRL (Global Regulatory Lead). This role will serve as a vital regulatory partner to local cross-functional teams and global stakeholders to support product launches and ensure compliance throughout the product lifecycle.

[HR Talk]
GE RA . 1 .

Product Registration & Maintenance
  • Develop regulatory strategies aligned with the product launch plan and GRL direction.
  • Prepare and submit MFDS applications in accordance with Korean regulations and GE HealthCare SOPs.
  • Collaborate with GRL and internal cross-functional teams to implement bridging strategies for marketing authorization.
  • Maintain product licenses by updating CMC, CCDS, and safety information as needed.
  • Review promotional and external communication materials for regulatory compliance.
  • Manage business licenses to support commercial operations.
Cross-functional Regulatory Support
  • Provide timely and accurate regulatory insights to internal teams (Medical, Commercial, Quality, etc.).
  • Participate in cross-functional projects and provide regulatory perspectives in decision-making processes.
External Collaboration & Regulatory Intelligence
  • Build and maintain effective working relationships with MFDS, MoHW, and relevant industry associations.
  • Monitor local regulatory changes and contribute to shaping policies aligned with GE HealthCares business strategy.
  • Represent GE HealthCare in regulatory forums when required.
Qualifications:
  • Minimum 1 year of experience in Regulatory Affairs within the pharmaceutical or healthcare industry or Health authority (MFDS etc.).
  • Degree in Pharmacy or Life Sciences. Pharmacist license is preferred.
  • Fluent in Korean and English (both written and verbal communication).
  • Solid understanding of Korean pharmaceutical regulations and regulatory procedures.
  • Knowledge of drug development and product lifecycle management.
Inclusion and Diversity

GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything youd expect from an organization with global strength and scale, and youll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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Additional Information

Relocation Assistance Provided: No
Locations - Location
Seoul, Seoul, Korea, Republic of, 04637

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