Regulatory Senior Executive
• Preparation of high quality, Chemistry, manufacturing and control (CMC) detailed regulatory documents using varied information sources. liaising closely with other Company's personnel to ensure accuracy of such records.
• Working to agreed deadlines and maintaining records to reflecting project status. responsible for highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving.
• Proactively pursuing process improvement and sharing of best practice.
• CMC experience
• Post-approval experience preferred
• Good written and oral communication and networking skills.
• Demonstrate ability to retain critical information.
• Be aware of the contents of a marketing authorization application.
• Demonstrate team working and effective time management skills.
• Be a dynamic and highly motivated individual
• Establish strong relationships and liaise effectively with company sites worldwide.
• Be proficient in the use of Word and excel.
• Demonstrate problem solving skills
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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