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 workplace, 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.

#J-18808-Ljbffr

📌 Director RA OSD/API (Toronto)
🏢 ThermoFisher Scientific
📍 Toronto