CMC RA Senior Manager/AD China submissions

Are you a highly motivated and experienced regulatory affairs professional looking for your next challenge? Thermo Fisher Scientific is seeking a talented Senior Manager/AD for China submissions to join our fast-paced and dynamic team. As a leader in the life sciences industry, Thermo Fisher Scientific is dedicated to providing innovative solutions that advance scientific research and improve patient outcomes. We are looking for a driven individual with a strong background in CMC regulatory affairs to lead our team in navigating the complex regulatory landscape in China. If you are ready to take your career to the next level and make a meaningful impact in the world of biotechnology, we want to hear from you.

1. Lead the team in developing and executing regulatory strategies for CMC submissions in China, ensuring compliance with local regulations and guidelines.
2. Collaborate with cross-functional teams to prepare and submit high-quality regulatory applications for new products, variations, and renewals.
3. Oversee the compilation and maintenance of regulatory documentation, including technical dossiers and other relevant documents.
4. Stay informed about changes in regulations and guidelines in China, and provide guidance and advice to the team and other stakeholders.
5. Serve as the main point of contact for regulatory agencies in China, including participating in meetings and managing correspondence.
6. Conduct thorough reviews of regulatory submissions and identify potential issues or risks, providing recommendations for resolution.
7. Mentor and train junior team members on regulatory requirements and best practices.
8. Collaborate with internal and external stakeholders to resolve regulatory issues and ensure timely approvals.
9. Keep accurate and up-to-date records of all regulatory activities and submissions.
10. Continuously monitor and assess the regulatory environment in China and make recommendations for process improvements and efficiencies.
11. Lead and participate in regulatory inspections and audits as needed.
12. Communicate effectively with management and provide regular updates on regulatory activities and progress.
13. Represent the company in industry and regulatory forums, staying abreast of industry trends and changes in regulations.
14. Adhere to company policies and procedures, as well as ethical and professional standards.
15. Contribute to the overall success of the regulatory affairs team by sharing knowledge, providing support, and promoting a collaborative and positive work environment.

According to JobzMall, the average salary range for a CMC RA Senior Manager/AD China submissions is between $150,000 and $200,000 per year. However, this can vary depending on factors such as location, company, and years of experience. Some senior managers/ADs in this role may earn upwards of $250,000 per year. It is important to note that salaries can also include bonuses and other benefits.

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.