Regulatory Affairs Specialist

Are you passionate about ensuring the safety and efficacy of pharmaceutical products? Do you thrive in a fast-paced environment where attention to detail is critical? Eli Lilly and Company is seeking a highly motivated Regulatory Affairs Specialist to join our team. In this role, you will play a vital role in ensuring compliance with all regulatory requirements for our products. We are looking for a candidate with a strong understanding of FDA regulations and guidelines, exceptional communication skills, and the ability to work collaboratively with cross-functional teams. If you are looking for a dynamic and challenging career in the pharmaceutical industry, we encourage you to apply for this exciting opportunity.

1. Ensure compliance with all regulatory requirements for pharmaceutical products.
2. Stay up-to-date with FDA regulations and guidelines, and communicate any changes or updates to the team.
3. Review and evaluate product submissions to ensure accuracy and completeness.
4. Collaborate with cross-functional teams to gather necessary information and documents for regulatory submissions.
5. Prepare and submit regulatory applications, reports, and other documents to regulatory agencies.
6. Communicate effectively with regulatory agencies and respond to any inquiries or requests for additional information.
7. Conduct thorough research and analysis to support regulatory strategies and decisions.
8. Maintain accurate and organized regulatory documentation and records.
9. Participate in internal and external audits and inspections.
10. Proactively identify and address any potential regulatory issues or concerns.
11. Provide guidance and support to other teams on regulatory requirements and processes.
12. Represent the company in meetings or conferences related to regulatory affairs.
13. Continuously monitor and improve processes to ensure efficiency and effectiveness.
14. Adhere to company policies and procedures and ensure compliance with all relevant laws and regulations.
15. Maintain confidentiality and handle sensitive information with professionalism and discretion.
16. Contribute to a positive and collaborative work environment.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Denver, CO, USA is between $68,000 and $98,000 per year. However, this can vary depending on factors such as industry, years of experience, and specific job responsibilities.

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.