Job Description
Are you a highly motivated and experienced regulatory affairs professional looking for an exciting new opportunity? Thermo Fisher Scientific is seeking a Global Reg Affairs Lead to and play a key role in driving regulatory compliance and approvals for our products worldwide. As a key member of our regulatory affairs team, you will have the opportunity to make a significant impact on our business and help us achieve our mission of improving the human condition through science. If you are a proactive, results-driven individual with a strong understanding of global regulations and a passion for driving innovation, we want to hear from you.
Join us and be a part of a dynamic and fast-paced environment where your skills and expertise will be valued and recognized. Develop and implement global regulatory strategies to ensure compliance with all relevant regulations and standards for Thermo Fisher Scientific products. Stay up-to-date with changes in global regulations and communicate potential impacts to the company’s product development and commercialization plans. Collaborate with cross-functional teams to ensure all regulatory requirements are met throughout the product lifecycle.
Prepare and submit regulatory submissions for product approvals, registrations, and listings in various countries. Act as the primary point of contact for regulatory agencies and provide timely responses to any requests or inquiries. Conduct regulatory assessments for new product launches and provide guidance on potential regulatory barriers and mitigation strategies. Lead and/or participate in regulatory agency meetings and negotiations to address any issues or concerns. Monitor and track regulatory submissions and approvals to ensure timely and accurate completion.
Provide guidance and support to internal teams on regulatory requirements and updates. Develop and maintain strong relationships with key stakeholders, including regulatory agencies, to influence and shape regulations impacting Thermo Fisher Scientific. Conduct internal audits to ensure compliance with regulatory requirements and identify any potential areas for improvement. Participate in industry forums and conferences to stay informed on emerging regulatory trends and best practices. Provide training and mentorship to other members of the regulatory affairs team.
Continuously improve and optimize regulatory processes to increase efficiency and effectiveness. Ensure all regulatory documentation and records are maintained in accordance with company policies and regulatory requirements. Thermo Fisher Scientific is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
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