Regulatory Affairs Specialist

Welcome to Eli Lilly and Company, where we strive to make life better for people around the world through innovative medicines and treatments. We are currently seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring that our products meet all regulatory requirements and are safe for patient use. If you are passionate about making a positive impact in the healthcare industry and have a strong understanding of regulatory guidelines, we encourage you to apply. Join us in our mission to improve lives and make a difference in the world.

1. Ensure compliance with all relevant regulatory guidelines and requirements for the development, registration, and post-marketing maintenance of pharmaceutical products.
2. Stay up-to-date with changing regulatory requirements and communicate any updates or changes to relevant departments within the company.
3. Prepare and submit regulatory submissions, including new drug applications, marketing authorization applications, and variations and amendments to existing applications.
4. Assist in the development and implementation of regulatory strategies for new products, including conducting gap analyses and risk assessments.
5. Communicate with regulatory authorities and respond to any queries or requests for information in a timely and accurate manner.
6. Work closely with cross-functional teams to ensure that all regulatory requirements are met throughout the product lifecycle.
7. Review and approve labeling and promotional materials to ensure compliance with regulatory guidelines and requirements.
8. Conduct regulatory training for internal stakeholders to ensure understanding and compliance with regulations.
9. Participate in regulatory agency inspections and audits, and assist in the preparation of responses to any findings.
10. Collaborate with global regulatory colleagues to ensure consistent and efficient processes and submissions across regions.
11. Maintain accurate and up-to-date records, documents, and databases related to regulatory submissions and approvals.
12. Proactively identify and communicate potential risks, issues, or delays in regulatory submissions or approvals and work with relevant teams to address them.
13. Contribute to the continuous improvement of regulatory processes and procedures within the company.
14. Represent the company in external meetings and conferences related to regulatory affairs and stay informed of industry trends and best practices.
15. Uphold the company's values and mission to make a positive impact on the healthcare industry and improve lives around the world.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Philadelphia, PA, USA is $67,000 - $120,000 per year. This salary range may vary depending on the specific company, experience level, and other factors.

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.