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Senior RA Executive RA Manager

Location Malaysia
Posted 21-August-2018
Senior RA Executive / RA Manager
[Description] Key responsibilities:

• Compile and submit registration dossiers to local authority to obtain regulatory approvals in a timely manner
• Maintain product licenses by ensuring that all renewals, variations, label updates are submitted and approved within the required time frame to ensure supply continuity and regulatory compliance
• Maintain proper record of regulatory submissions and approvals and update databases for RA information /documents
• Review local promotional materials
• Represent Regulatory Affairs in project teams to provide relevant regulatory advice
• Perform and handle Quality Assurance activities which includes but not limited to: product release, product return and product recall
• Manage relabelling for all products to ensure the compliance of GMP and GDP standard, company’s and relevant Thai regulatory requirements
• Ensure all necessary local Quality SOPs are in place, reviewed or updated periodically
• Conduct GMP and SOP training to relevant employees in the Thailand office
• Obtain knowledge of assigned therapy, market environment and products.

To succeed in the Senior Regulatory Affairs / RA Manager, you will need to be knowledgeable in marketing concepts with good strategical thinking.

Key requirements:

• Bachelor’s degree in pharmaceutical or other related scientific fields
• Masters degree in business or commercial will be an advantage
• At least three years’ experience in commercial and/or sales function in pharmaceutical business
• Experience in product management is required
• Strong interpersonal and communication skills
• Highly self-motivated and work effectively under matrix organisation
• Good computers skills
Salary details
USD 40000.00

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