Regulatory Affairs Specialist

Welcome to Eli Lilly and Company, where we are committed to making life better for people around the world through our innovative medicines and healthcare solutions. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring the safety, efficacy, and compliance of our products with regulatory requirements. We are seeking a highly motivated and detail-oriented individual with a strong understanding of regulatory affairs and experience in the pharmaceutical industry. If you are passionate about making a difference in the lives of patients and have the necessary qualifications, we invite you to join our team and be a part of our mission to improve global health.

1. Ensure compliance with all applicable regulatory requirements for the development, registration, and maintenance of our products.
2. Review and interpret regulatory guidelines and communicate changes and updates to relevant teams.
3. Prepare and submit regulatory submissions, including new drug applications, amendments, and annual reports.
4. Conduct thorough reviews of product labeling to ensure accuracy and compliance with regulations.
5. Collaborate with cross-functional teams to provide regulatory guidance and support throughout the product development process.
6. Identify and escalate potential regulatory issues or risks to management.
7. Maintain up-to-date knowledge of relevant regulations and industry trends.
8. Communicate with regulatory agencies as needed to support product registrations and approvals.
9. Coordinate and lead regulatory inspections and audits.
10. Participate in the development and implementation of regulatory training programs for internal stakeholders.
11. Support the development and maintenance of regulatory policies and procedures.
12. Ensure timely completion of all regulatory tasks and submissions within set deadlines.
13. Maintain accurate and organized documentation of all regulatory activities.
14. Keep abreast of changes in legislation and regulations that may impact product development and registration.
15. Demonstrate a strong commitment to the company's mission and values, and adhere to all company policies and procedures.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Nashville, TN, USA is between $64,000 and $82,000 per year. However, this can vary depending on factors such as years of experience, education level, and specific industry or company. Some companies may offer higher salaries for more experienced or specialized professionals in this field. It is recommended to research specific job postings and companies in the Nashville area to get a better understanding of salary expectations.

Eli Lilly and Company is an American pharmaceutical company headquartered in Indianapolis, Indiana, with offices in 18 countries. Its products are sold in approximately 125 countries. The company was founded in 1876 by, and named after, Col. Eli Lilly, a pharmaceutical chemist and veteran of the American Civil War.