Assistant RA Manager/Manager
Detail posisi
Kewajiban
• Registration of new products as plan to ensure the launch plan for product portfolio will be as scheduled.
• Responsible for product license renewal, company's license, GMP clearance, amendment and annual report.
• Maintain the registration licenses up to date throughout the lifecycle of product as required by local regulations.
• Ensure all changes and quality issues relevant to regulatory activities are well-managed.
• Provide regulatory input/ recommendation to ensure the compliance with regulatory requirements.
• Establish and maintain excellent working relationships with local health authority and other local regulatory agencies, as required.
• Independently contribute to routine regulatory activities for product portfolio assigned.
• Coordinate all relating responsibilities for Bioavailability (BA) /Bioequivalent (BE), Clinical study center and regulatory authority.
• Pharmacovigilance coordinator to improve public health and safety in relation to the use of pharmaceutical product.
Kualifikasi
• Bachelor's degree in Pharmaceutical Sciences.
• At least 5-8 years experience in area of Regulatory Affairs responsible for pharmaceutical products.
• Very good knowledge of drug act and the registration regulations, Good knowledge of the Regulatory concept and principles.
• Good command in English particularly writing skill.
• Computer literacy-skill to use business applications.
• Actively responsible, well organized and able to work as a team with a positive attitude and open minded.
• Excellent and effective communication, negotiation, inter-personal skills, Problem solving and decision making.
• Good collaboration with and communication to all relevant stakeholders.