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About this position

The Regulatory Staff is responsible for providing regulatory strategies and supporting teams to obtain worldwide regulatory approval for molecular products, while ensuring compliance with regulations.

Responsibilities

• Responsible for providing regulatory strategies under the direction of the head of division.
• Support teams to obtain worldwide regulatory approval or clearance for company molecular products and develop global regulatory strategies for new and modified products.
• Participate in and provide input to project to assure that product registrations and licensing applications (original submission and subsequent product enhancements) meet regulatory requirements.
• Maintain technical expertise through familiarity with the literature, attendance at professional meetings and participation in team meetings. Interpret new or existing regulatory requirements procedure.
• Review and advise on labelling, product claims, marketing brochures, and other publications to ensure compliance with regulations. Comply with applicable Corporate and Divisional Policies and procedures.

Requirements

• Bachelor degree in Pharmacy and have STRA (active)
• Regulatory Knowledge of (as applicable)
• At least 1 years relevant experience in industry or distribution medical device company within the regulatory affairs discipline
• Knowledge of Indonesia medical device regulatory requirements
• Experience in registration all categorize medical device in MoH and other license in related ministries
• Excellent verbal and written English communication skills.
• Computer literate with prior database processing experience.
• Extraordinary organizational skills.

Benefits