Director RA OSD/API

Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
As part of the Thermo Fisher Scientific team, youu2019ll 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 worldu2019s 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:
u2022 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
u2022 Preferred Fields of Study: Life Sciences, Pharmacy, Chemistry, Microbiology, or related field
u2022 Comprehensive knowledge of global regulatory requirements, particularly FDA, EMA, and ICH guidelines
u2022 Successful track record of regulatory submissions and agency interactions
u2022 Leadership experience managing and mentoring multi-site teams
u2022 Experience in regulatory strategy development and implementation
u2022 Demonstrated expertise in regulatory compliance and quality management systems
u2022 Advanced project management and organizational skills
u2022 Excellent verbal and written communication abilities
u2022 Effective negotiation and influencing skills
u2022 Ability to work effectively in a matrix organization
u2022 Business acumen and strategic thinking capabilities
u2022 Proficiency in standard office technology and regulatory systems
u2022 Fluency in English required; additional language skills advantageous
u2022 Ability to travel 25-50% of time, primarily international
u2022 Experience with CDMO/pharmaceutical services preferred
u2022 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 $150,000.00u2013$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.