Manager/Sr. Manager Regulatory Affairs, Clinical FSP

Are you passionate about making a difference in the world of healthcare and life sciences? Do you have a strong background in regulatory affairs and a desire to lead a high-performing team? If so, we have an exciting opportunity for you at Thermo Fisher Scientific. We are seeking a motivated and experienced Manager/Sr. Manager of Regulatory Affairs to join our Clinical FSP team. In this role, you will be responsible for ensuring that our clinical trials comply with all regulatory requirements, ultimately helping to bring life-saving treatments to patients. The ideal candidate will have a minimum of [X] years of regulatory affairs experience, a deep understanding of global regulatory requirements, and excellent leadership skills. Join us and be a part of our mission to advance scientific discovery and improve lives.

1. Lead a team of regulatory affairs professionals to ensure compliance with all regulatory requirements for clinical trials.
2. Develop and implement regulatory strategies to support the successful execution of clinical trials.
3. Keep up-to-date with global regulatory requirements and communicate any changes or updates to the team.
4. Collaborate with cross-functional teams to ensure timely and accurate submissions to regulatory agencies.
5. Manage relationships with regulatory agencies and participate in meetings and teleconferences as needed.
6. Review and provide input on clinical trial protocols, informed consent forms, and other essential documents to ensure regulatory compliance.
7. Oversee the preparation and submission of regulatory documents, including INDs, NDAs, and amendments.
8. Provide guidance and mentorship to team members, supporting their professional development and growth.
9. Ensure timely and accurate reporting of regulatory activities to senior management.
10. Contribute to the development and improvement of internal processes and procedures related to regulatory affairs.
11. Stay informed about industry trends and best practices in regulatory affairs and share knowledge with the team.
12. Maintain a high level of quality and accuracy in all regulatory submissions and communications.
13. Serve as a subject matter expert and point of contact for regulatory questions and issues.
14. Represent the company in regulatory inspections and audits, ensuring compliance with all applicable regulations.
15. Foster a culture of compliance and ethical behavior within the team and across the organization.

According to JobzMall, the average salary range for a Manager/Sr. Manager Regulatory Affairs, Clinical FSP is $100,000 to $150,000 per year. This can vary depending on factors such as location, company size, and level of experience. Some companies may also offer additional benefits, such as bonuses and stock options, which can increase the overall compensation package.

Thermo Fisher Scientific is a U.S.-based provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.