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

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• 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

🎯 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

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development opportunities