Regulatory Affairs Professional
6 days ago
Parexel is seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) for client dedicated projects in various locations. This role can be office or home based, offering flexibility and work-life balance.
The successful candidate will play a vital role in worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological products. Principal tasks include developing submission strategies, assessing change controls, reviewing study reports, and managing projects within Regulatory Information Management systems.
Requirements:
• University-level education in Life Sciences or equivalent experience
• Previous experience in regulatory affairs, particularly related to technical/CMC/quality in the pharmaceutical industry
• Strong knowledge of CMC and post-approval regulatory requirements
• Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault
• Fluency in English (written and spoken), with French, Italian, and German being a strong plus
Estimated Salary: $80,000 - $110,000 per annum, depending on location and experience.
Benefits: Comprehensive benefits package, including health insurance, retirement plan, and paid time off.
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