Regulatory Affairs Specialist

Are you a detail-oriented and highly organized individual with a passion for ensuring compliance and regulatory adherence? Do you thrive in a fast-paced environment and have a strong understanding of FDA regulations and guidelines? If so, we have an exciting opportunity for you as a Regulatory Affairs Specialist at Eli Lilly and Company.As a global pharmaceutical company dedicated to improving the lives of patients, we are seeking a dynamic and experienced individual to join our Regulatory Affairs team. In this role, you will be responsible for ensuring that all of our products meet the necessary regulatory requirements and standards, ensuring the safety and efficacy of our medications. If you have a strong background in regulatory affairs and a desire to make a difference in the healthcare industry, we encourage you to apply for this position.

1. Develop and maintain a comprehensive understanding of FDA regulations and guidelines related to pharmaceutical products.
2. Monitor and analyze changes in regulatory requirements and communicate any potential impact to the company.
3. Collaborate with cross-functional teams to ensure compliance with regulatory requirements for all products.
4. Prepare and submit regulatory submissions, including new drug applications, amendments, and annual reports.
5. Review and approve labeling, packaging, and advertising materials to ensure compliance with regulatory standards.
6. Conduct regulatory assessments and risk evaluations to identify potential compliance issues.
7. Serve as the primary point of contact for regulatory agencies and respond to inquiries and requests for information.
8. Conduct internal audits and assist with external regulatory inspections.
9. Maintain accurate and up-to-date regulatory documentation and records.
10. Stay informed of industry trends and developments related to regulatory affairs and make recommendations for process improvements.
11. Train and educate colleagues on regulatory requirements and changes.
12. Participate in the development and implementation of company policies and procedures related to regulatory compliance.
13. Work closely with other departments to ensure timely and successful completion of regulatory submissions.
14. Continuously monitor and assess the effectiveness of regulatory processes and make recommendations for improvement.
15. Maintain a high level of professionalism and confidentiality when dealing with sensitive regulatory information.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Tampa, FL, USA is between $72,000 and $92,000 per year. This may vary depending on factors such as experience, education, and the specific industry or company the specialist is working in. Additionally, bonuses and benefits may also impact the overall salary.

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.