When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
How will you make an impact?
The Director of Global Strategic Regulatory and Clinical Affairs will be responsible for providing corporate regulatory and clinical leadership and expertise to drive alignment and harmonization of global regulatory and clinical policies across Thermo Fisher Scientific's Groups and Divisions. The position will utilize regulatory and clinical intelligence to create and maintain corporate policies and develop strategic practices to address regulation and legislative changes for global regulatory and clinical compliance. The incumbent will be part of the Thermo Fisher Scientific Corporate Quality and Regulatory team based in the U.S. and will serve as an active leader of Regulatory and Clinical Affairs within the Global Quality and Regulatory Council. This role will manage the global Corporate Regulatory and Clinical resources to establish the necessary QARA network between Divisions, their sites and global regulatory organizations and authorities.
What will you do?
- Establish and Chair the Company's Regulatory and Clinical Affairs Council
- Work efficiently with cross-divisional functions and businesses to drive corporate regulatory and clinical business objectives.
- Be responsible for the corporate policy Controlling External Regulatory and Clinical standards.
- Pro-actively evaluate and interpret relevant global regulations, guidelines and evolving regulatory trends which impact Company products and services.
- Maintain up-to-date knowledge of international and domestic regulatory and clinical requirements encompassing research, medical device, IVD and pharmaceutical products.
- Assure effective communication and execution of corporate policies.
- Provide strategic regulatory and clinical leadership driving corporate initiatives, determining risk and impact based on intelligence across mature and immature markets.
- Serve as the corporate interface with external organizations, participating in public meetings, industry conferences and workshops applicable to the Company's regulatory agenda.
- Foster collaborative relationships with corporate partners.
- Identify opportunities to strengthen the efficiency and effectiveness of regional and global regulatory and clinical affairs teams/organizations.
- Lead cross-divisional internal regulatory expert/working groups in order to further develop regulatory competencies within the company.
How will you get here?
- Bachelor's degree or equivalent in STEM technical subject matter (e.g. chemistry, biochemistry, biology, etc.)
- A minimum of 15 years professional regulatory experience with competency in the areas of medical device, pharmaceutical, research and in vitro diagnostic products
- Excellent working knowledge of up-to-date domestic, international, and company regulatory compliance
- Ability to work independently, taking responsibility for the management of processes, projects and timelines
- Ability to influence and lead change across Groups and Divisions to implement new programs, policies and processes
- Ability to author standard operating procedures and company policies
- Ability to drive results in a matrix organization, especially having representatives from different cultures come together, embracing diversity
- Strong demonstration of leadership capabilities with experience in leading programs and projects
25-40% regional and international travel is expected
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.
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.
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