Associate Director, Regulatory Affairs – Clinical Trials (FSP Strategy & Business Development)
Core
Interpret and disseminate global regulations, guidelines, and emerging industry developments to ensure compliance and bring innovative products to market.
Role type
Senior Staff Regulatory Affairs Specialist
Builds
Innovative products for global customers
Domain
Life Sciences / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory framework knowledge, regulatory submissions and filings, strategic regulatory impact evaluation, regulatory information systems management, policy and guideline development, post-market surveillance and vigilance
Preferred skills
Science, engineering, pharmacy, or related field background
Technologies
Regulatory software tools and systems (RIMS)
Responsibilities
Interpret and disseminate global regulations, contribute to developing and implementing regulatory strategies, maintain compliance throughout product lifecycles, support continuous improvement of regulatory tools and information systems, liaise with regulatory authorities, trade associations, and professional bodies, manage and improve regulatory information systems
Seniority
Senior Staff, hands-on IC