담당업무

PURPOSE
The Regulatory Affairs Specialist is responsible for ensuring that regulatory strategies and regulatory activities are effectively
executed to meet the business objectives and legal requirements in Korea
ROLES & RESPONSIBILITES
? Maintains the product license by applicable RA activities and ensures compliance with local law, regulations, guideline by
monitoring and complies with internal standard operating procedures
? Serves as a liaison between regulatory bodies and operating divisions of the company
? Prepares and submits applications and reports to applicable regulatory agencies
? Responds to requests for information from regulatory bodies
? Involved in Regional RA projects and respond in timely manner on queries based on Local regulations
? Monitors regulatory affairs and the effect changes will have on company operations
? Develops and maintains professional relationships in federal, state, and local regulatory agencies
? Manage independently all RA works to support commercial business success and compliance to local regulations
? Communicate with all stakeholders on regulatory plan and strategies and propose best resolution at the regulatory
perspective to minimize any commercial impact in timely manner if any urgent situation
? Performs other related duties as assigned 

자격요건

QUALIFICATION
? Education : Bachelor’s degree major in Biochemistry, Pharmacy and/or Biological or Life science area at least
Preferably having registration experience in Anti-cancer drug, Orphan drug, or Diabetic drug
? Language : English business level
? Experience : Over 5 years-experience in Regulatory affairs in pharma industry
COMPETENCIES REQUIRED
? Good command of spoken and written English
? Proficient communication skills with internal team, external partner and Health Authority (MFDS) on matters to be
negotiate if necessary.
? Passion on new business development and willingness on overcoming challenges
? Extensive knowledge of applicable government regulations.
? Ability to inform and educate managers and department heads on regulations and policies that require compliance.
? Excellent analytical, problem-solving, and strategic planning skills
? Proficient with MS office Suite and Hangul
? Good team player