|
• Bachelor’s Degree in Pharmacy, Life Sciences or professional equivalent
• 7+ years regulatory expertise in country-specific requirements for medicinal products including the supervision and creation of country-specific regulatory submission documents and coordinating delivery to submission plans, artwork review, communication with the Health Authority
• Experience with working in a large regulatory organization where some tasks are managed centrally and some at a local level
• Knowledge of local pharmaceutical legislation, relevant guidelines and requirements
• Excellent regulatory project management skill set
• Regulatory technology experience is a plus
• Excellent organization and communication skills
• Ability to work to tight timelines
• Good team player
• Excellent written and verbal communication skills in English
• Strong computer skills, including MS Office applications, and preferably, experience with Regulatory Information management and artwork systems
|