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About the Role

As Director of Regulatory Affairs at Thermo Fisher Scientific, you will lead strategic initiatives to ensure regulatory compliance and drive business growth across multiple regions. This leadership role involves developing and implementing regulatory strategies, mentoring teams, and managing relationships with regulatory agencies worldwide. You will oversee regulatory compliance, provide expert guidance, and ensure successful product submissions across various jurisdictions, influencing global regulatory policy and driving innovation.

Responsibilities

Lead strategic initiatives to ensure regulatory compliance and drive business growth.
Develop and implement regulatory strategies.
Mentor teams and manage relationships with regulatory agencies worldwide.
Oversee regulatory compliance activities.
Provide expert guidance on regulatory requirements.
Ensure successful product submissions across various jurisdictions.
Shape regulatory strategy for product development, manufacturing, and commercialization.
Maintain the highest standards of compliance.
Influence global regulatory policy and drive innovation in 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.
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.
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).

Skills

Regulatory Affairs
Manufacturing Operations
FDA
EMA
ICH guidelines
Regulatory Submissions
Agency Interactions
Team Management
Mentoring
Regulatory Strategy
Regulatory Compliance
Quality Management Systems
Project Management
Organizational Skills
Communication
Negotiation
Influencing Skills
Matrix Organization Navigation
Business Acumen
Strategic Thinking
Office Technology Proficiency
Regulatory Systems Proficiency
English Fluency
CDMO/Pharmaceutical Services
Industry Trend Knowledge
Professional Association Participation

Location

Ohio

Work Type

Office
Standard (Mon-Fri)

Experience Level

6 years of experience with Advanced Degree
8 years of experience with Bachelor's Degree

Education Level

Advanced Degree
Bachelor's Degree
Life Sciences
Pharmacy
Chemistry
Microbiology
Related field

Salary/Compensations

$150,000.00–$218,000.00

About the Company

Thermo Fisher Scientific is dedicated to enabling customers to make the world healthier, cleaner and safer.
We provide global teams with resources for individual career goals.
We help take science a step beyond by developing solutions for global challenges like environmental protection, food safety, and cancer cures.