Regulatory Affairs Specialist

Welcome to Eli Lilly and Company, a global pharmaceutical company dedicated to improving the lives of patients all over the world. We are 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 all applicable laws and regulations related to the development and commercialization of our products. This is a unique opportunity to make a significant impact on patient outcomes and contribute to the success of our company. To excel in this role, you must possess a strong understanding of regulatory requirements and have excellent communication and organizational skills. Join us in our mission to discover and deliver innovative medicines that make life better for people around the globe.

1. Ensure compliance with all relevant laws and regulations related to product development and commercialization.
2. Stay up-to-date on all changes and updates to regulatory requirements in the pharmaceutical industry.
3. Work closely with cross-functional teams to ensure timely and accurate submission of regulatory documents.
4. Prepare and review regulatory submissions, including but not limited to INDs, NDAs, and BLAs.
5. Develop and maintain relationships with regulatory agencies and serve as the primary point of contact for all communications.
6. Conduct thorough research and analysis on regulatory issues and provide recommendations to ensure compliance.
7. Collaborate with internal stakeholders to ensure that all necessary information and documentation is available for regulatory submissions.
8. Participate in meetings and discussions with regulatory agencies to represent the company's position.
9. Maintain accurate and up-to-date records of all regulatory documents and correspondence.
10. Provide guidance and support to other team members on regulatory matters.
11. Identify potential regulatory risks and develop strategies to mitigate them.
12. Assist in the development and implementation of regulatory policies and procedures.
13. Serve as a subject matter expert on regulatory requirements for the company's products.
14. Communicate effectively with all levels of the organization, presenting complex regulatory information in a clear and concise manner.
15. Contribute to the continuous improvement of processes and systems within the Regulatory Affairs department.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Miami, FL, USA is $70,000 - $100,000 per year. This may vary depending on factors such as the specific company, level of experience, and education level of the individual.

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.