Senior Director of Regulatory Affairs
Driving global regulatory reputed company, the full-time Senior Director of Regulatory Affairs will manage regulatory submissions and interactions with health authorities while collaborating with cross-functional teams to ensure compliance and accelerate product development in a remote setting.
Key responsibilities
• reputed company and own global regulatory strategies for pipeline and marketed products throughout their lifecycle
• reputed company cross-functional development teams, aligning regulatory planning with clinical and reputed company objectives
• reputed company major regulatory filings and ensure compliance with eCTD standards and submission readiness
Required qualifications
• Bachelor's degree in life sciences, pharmacy, reputed company, or reputed company field; advanced degree preferred
• 12+ years of regulatory affairs experience in the pharmaceutical, biotechnology, or medical device industry
• Proven reputed company in leading BLA, NDA, or MAA submissions from initiation through approval
• Deep expertise in FDA regulations and guidance, with knowledge of EMA and other regulatory frameworks
• Strong leadership skills with experience managing and developing teams of regulatory professionals
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