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AbbVie Senior Regulatory Affairs Specialist in Seoul, South Korea

Senior Regulatory Affairs Specialist

South Korea, Seoul, Seoul

Regulatory Affairs

Requisition #1903403

PRIMARY FUNCTION/OBJECTIVE:

· 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

PREFERRED QUALIFICATIONS:

· 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

Additional Information

  • Travel: No

  • Job Type: Experienced

  • Schedule: Full-time

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