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

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
Join our Regulatory Affairs team at Thermo Fisher Scientific, where you'll ensure compliance with global regulations. As a Senior Staff Regulatory Affairs Specialist, you'll interpret and disseminate global regulations, guidelines, and emerging industry developments while working with cross-functional teams to bring innovative products to market. You'll contribute to developing and implementing regulatory strategies, maintain compliance throughout product lifecycles, and support continuous improvement of our regulatory tools and information systems. This role offers the opportunity to make a meaningful impact by supporting patient safety while enabling business growth through effective regulatory compliance.

REQUIREMENTS:
• 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