Director RA OSDAPI

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds 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 youll make a significant impact on global healthcare through innovative solutions. As Director of Regulatory Affairs youll 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.

Youll oversee regulatory compliance activities provide expert guidance on regulatory requirements and ensure successful product submissions across various jurisdictions. Working closely with cross-functional teams youll 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 Bachelors 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 $150000.00$218000.00.