Regulatory Affairs Specialist

Welcome to Eli Lilly and Company, a global pharmaceutical company dedicated to improving the lives of patients around the world. 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 compliance with regulatory requirements in the development, registration, and maintenance of our products. This position requires a strong understanding of global regulatory guidelines and the ability to effectively communicate with cross-functional teams. If you are passionate about making a difference in the healthcare industry and have the necessary qualifications, we would love for you to join us in our mission to make life better for people everywhere.

1. Ensure compliance with global regulatory requirements: The primary responsibility of the Regulatory Affairs Specialist is to ensure that all products developed and maintained by Eli Lilly and Company comply with regulatory guidelines set by governing bodies around the world.
2. Stay updated on regulatory guidelines: The specialist must stay up-to-date with changes in global regulatory guidelines and communicate any updates to the team.
3. Collaborate with cross-functional teams: The specialist will work closely with cross-functional teams, including research and development, marketing, quality assurance, and legal, to ensure that all products meet regulatory requirements.
4. Prepare and submit regulatory documents: The specialist will be responsible for preparing and submitting all necessary regulatory documents to obtain and maintain marketing authorization for our products.
5. Coordinate and lead regulatory inspections: The specialist will coordinate and lead regulatory inspections to ensure compliance and address any issues that may arise.
6. Conduct regulatory assessments: The specialist will conduct assessments to determine the impact of new regulations on existing products and provide recommendations for compliance.
7. Communicate with regulatory agencies: The specialist will serve as the main point of contact with regulatory agencies and respond to any inquiries or requests for information in a timely and accurate manner.
8. Ensure product labeling compliance: The specialist will review and approve product labeling to ensure compliance with regulatory requirements.
9. Maintain regulatory documentation: The specialist will maintain accurate and up-to-date regulatory documentation, including product registration files and submission records.
10. Provide training and guidance: The specialist will provide training and guidance to internal teams on regulatory requirements and ensure that all employees are aware of their responsibilities in maintaining compliance.
11. Participate in internal and external audits: The specialist will participate in internal and external audits to ensure compliance with regulatory requirements and identify areas for improvement.
12. Contribute to continuous improvement: The specialist will actively contribute to continuous improvement initiatives to enhance the efficiency and effectiveness of the regulatory affairs processes at Eli Lilly and Company.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Washington, DC, USA is $80,000 - $120,000 per year. This range can vary depending on factors such as experience, education, and specific job responsibilities. Generally, those with more experience and advanced degrees in the field may earn higher salaries.

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.