Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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 make a significant impact on global healthcare through innovative solutions. As Director of Regulatory Affairs, you'll lead strategic initiatives to ensure regulatory compliance while driving business growth across multiple regions. This key leadership role involves developing and implementing regulatory strategies, mentoring teams, and managing critical relationships with regulatory agencies worldwide.
You'll oversee regulatory compliance activities, provide expert guidance on regulatory requirements, and ensure successful product submissions across various jurisdictions. Working closely with cross-functional teams, you'll shape regulatory strategy for product development, manufacturing, and commercialization while maintaining the highest standards of compliance. This role offers the opportunity to influence global regulatory policy and drive innovation in our regulatory approaches.
REQUIREMENTS:
• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in pharmaceutical/medical device regulatory affairs with emphasis on manufacturing operations
• Preferred Fields of Study: Life Sciences, Pharmacy, Chemistry, Microbiology, or related field
• Comprehensive knowledge of global regulatory requirements, particularly FDA, EMA, and ICH guidelines
• Successful track record of regulatory submissions and agency interactions
• Leadership experience managing and mentoring multi-site teams
• Experience in regulatory strategy development and implementation
• Demonstrated expertise in regulatory compliance and quality management systems
• Advanced project management and organizational skills
• Excellent verbal and written communication abilities
• Effective negotiation and influencing skills
• Ability to work effectively in a matrix organization
• Business acumen and strategic thinking capabilities
• Proficiency in standard office technology and regulatory systems
• Fluency in English required; additional language skills advantageous
• Ability to travel 25-50% of time, primarily international
• Experience with CDMO/pharmaceutical services preferred
• Knowledge of current industry trends and participation in professional associations (e.g., TOPRA, PDA)
Compensation
The salary range estimated for this position based in Ohio is $150,000.00–$218,000.00.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.
All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.
If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.
Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer.