Ensure compliance with global regulations
Interpret and disseminate global regulations, guidelines, and emerging industry developments
Work with cross-functional teams to bring innovative products to market
Contribute to developing and implementing regulatory strategies
Maintain compliance throughout product lifecycles
Support continuous improvement of regulatory tools and information systems
Make a meaningful impact by supporting patient safety while enabling business growth through effective regulatory compliance

Advanced Degree plus 6 years of regulatory affairs experience, or Bachelor's Degree plus 8 years of regulatory affairs experience
Preferred Fields of Study: science, engineering, pharmacy, or related field
In-depth knowledge of global regulatory requirements and frameworks, particularly relating to emerging technologies
Proven track record in regulatory submissions and filings with global authorities
Strong ability to evaluate regulatory impact on products and provide strategic recommendations
Experience managing and improving regulatory information systems (RIMS)
Expert communication and presentation skills for conveying complex regulatory concepts
Advanced project management capabilities to handle multiple complex initiatives
Demonstrated ability to collaborate and engage with key stakeholders
Experience liaising with regulatory authorities, trade associations, and professional bodies
Proficiency with regulatory software tools and systems
Ability to develop regulatory policies and guidelines
Experience in post-market surveillance and vigilance activities
Strong cross-functional collaboration skills
Ability to work effectively in a global environment

Associate Director, Regulatory Affairs – Clinical Trials, FSP Strategy & Business Development

Key skills