Principal Reg Affairs Specialist

At Thermo Fisher Scientific, we are looking for a highly-motivated, organized, and detail-oriented Principal Regulatory Affairs Specialist to join our team. This is a key role in our Regulatory Affairs department, responsible for ensuring that all regulatory requirements are met in a timely and accurate manner. The ideal candidate will have a strong background in regulatory affairs and a passion for staying on top of changing regulations.We are looking for a candidate who has excellent communication and problem-solving skills, and is highly knowledgeable in regulatory requirements and processes. A Bachelor's degree in a relevant field, along with a minimum of 8 years of experience in a regulatory affairs position, is required. In addition, the successful candidate will have a deep knowledge of applicable global regulations and standards, and will have a proven track record of successful product submissions and compliance.If you are a team-oriented, motivated individual with a passion for regulatory affairs, we invite you to apply for this position. We look forward to hearing from you.

Responsibilities:

1. Ensure all regulatory requirements are met in a timely and accurate manner.
2. Use excellent communication and problem-solving skills to keep up with changing regulations.
3. Maintain a deep knowledge of applicable global regulations and standards.
4. Develop and implement successful product submission and compliance strategies.
5. Monitor and report on regulatory changes.
6. Prepare and manage regulatory documents and submissions.
7. Maintain records of regulatory filings and submissions.
8. Provide regulatory advice and guidance to team members.
9. Liaise with regulatory bodies to resolve queries.
10. Develop and implement training programs for team members.

According to JobzMall, the average salary range for a Principal Reg Affairs Specialist is $55,000 to $80,000. This range can vary depending on experience, location, and other factors.

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.