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Job Description

[JOB DESCRTIPTION] REGULATORY AFFAIRS ASSOCIATE (3M Contract)

MAIN RESPONSIBILITIES:

• Support Local Regulatory Representatives for local regulatory submissions as appropriate.
• Provide labelling and artwork support (competitive label analyses, country prescribing Information development, product Regional Text Label development, artwork request and communication etc.).
• Provide local regulatory operational support (GRIP request for submission dossier archiving and monitoring and tracking RIM Activities and Regulatory Objectives etc).
• Monitor regulatory intelligence from various sources such as KRPIA, KoBIA, KMDI and etc and disseminate to responsible stakeholders.
• Provide logistics support for regulatory outsourcing contract, meeting and travels.

REQUIREMENTS:

• Solid scientific background (university degree of chemistry, life sciences, pharmacy, medicines). Pharmacist is preferred.
• Good understanding of the pharmaceutical industry and the Korean regulations.
• Experience in regulatory affairs is preferred.
• Spoken and written English communication skill.
• Ability to rapidly adapt to different issues and projects at one time.
• Ability to work in an international environment.
• Good interpersonal skills.
• Excellent communication skills.
• Demonstrates high level of self-motivation and professional commitment.