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Regulatory Affairs Executive job at Abbott | Abbott Careers

The primary scope of the Regulatory Affairs Executive role is including:

• Execution: Ensure the implementation of RA strategies according to the guidance of the RA director/manager in preparing dossier and registering with the Ministry of Health to obtain and maintain product licenses; product advertising certification; internal review promotional material to ensure compliance.
• External engagement with Health authority: follows up with Health authority to ensure product registration smoothly, got the product licenses on time with key claims protected, gather regulatory intelligence.
• Cross-functional support: provide information related to regulation and product to support cross functions team, perform RA team administrative tasks.

MAIN RESPONSIBILITIES

• Preparing dossier for Products registration, product advertising registration
• Internal Review Promotion Materials
• Follows up with Health Authority
• Negotiation with Health Authority
• Gather regulatory intelligence.
• Provide product technical information, regulation to support other functions
• Act as regulatory consultant to other functions
• Perform administrative tasks

Work Experience

Experience Details

• At least 2 years
• Years of experience in overall Nutrition/ Pharmacy/ Medicine industry or specific in regulatory affairs

Education

Field of Study/ Qualification

• Bachelor's degree
• Pharmacy, Nutrition or Medicine

CORE Skills Required

Professional Skill

(Technical skills required for role)

• Good technical knowledge on nutrition or pharmacy or medicine.
• Communication skill: Clearly conveying information and ideas to Health authority to engages and helps them understand and accept company’s submission.
• Follow-up: Closely monitoring the product registration process and timely report to RA director/manager, respond to Health authority's request under instruction from RA director/manager
• Negotiation skill: Effectively exploring alternatives and positions to reach outcomes that gain the acceptance for product submission

Behavioral / Leadership Skill

Adaptability, Initiative, Innovation, Integrity, Teamwork

Language Skill

English B1 (Reading, Writing, Listening, Speaking)

Computer Skill

Microsoft office