AbbVie Senior Regulatory Affairs Specialist in Seoul, South Korea
Senior Regulatory Affairs Specialist
South Korea, Seoul, Seoul
· To manage/assist with the preparation of regulatory submissions of company products in order to obtain necessary regulatory approvals
· To provide regulatory input on regulatory matters to company personnel.
CORE JOB RESPONSIBILITIES:
· Manage registration of new/line extension products, variations to marketed products to ensure regulatory approvals are achieved in accordance with Company objectives.
· Coordinate responses to deficiency letters and other requests for data in agreed timelines
· Prepare safety update reports, certified product details and import permits
· Maintain contact with governmental officials of Korea MFDS to facilitate evaluation processes.
· Liaise with operations department and others to maintain product changes and ensure these comply with regulations.
· Review labeling, product information and promotional materials for compliance with relevant regulations and codes.
· Provide support for marketing plans and launch teams
· Maintain good knowledge of the relevant Regulations & Code.
· Back-up role of RA manager
· University degree in appropriate discipline
· Minimum 3 years of experiences in regulatory affairs
· Knowledge of pharmaceutical affairs law and MFDS guidelines
· Good at communication skill, English and computer skill
Job Type: Experienced