Regulatory Affairs Specialist

Welcome to Eli Lilly and Company, a global pharmaceutical company dedicated to improving the lives of people around the world. We are currently seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team. In this role, you will be responsible for ensuring compliance with all regulatory requirements and supporting the development and approval of our innovative medical products. To excel in this position, we are seeking candidates with a strong understanding of FDA regulations, excellent communication skills, and the ability to work collaboratively in a fast-paced environment. If you are passionate about making a difference in the healthcare industry and have a desire to continuously learn and grow, we encourage you to apply for this exciting opportunity.

1. Develop and maintain a deep understanding of FDA regulations and other relevant regulatory requirements.
2. Ensure compliance with all regulatory requirements for the development, approval, and marketing of medical products.
3. Prepare and submit regulatory filings, including new drug applications, amendments, and annual reports.
4. Collaborate with cross-functional teams to support the development and approval of new medical products.
5. Conduct thorough research and analysis to identify potential regulatory hurdles and provide recommendations to mitigate risks.
6. Participate in meetings with regulatory agencies and respond to any inquiries or requests for additional information.
7. Monitor changes in regulations and communicate any potential impact to the organization.
8. Maintain accurate and up-to-date documentation of all regulatory activities.
9. Communicate with internal and external stakeholders to ensure timely and efficient completion of regulatory processes.
10. Provide guidance and support to other team members on regulatory affairs matters.
11. Stay current on industry trends and developments to continuously improve processes and procedures.
12. Demonstrate a strong commitment to ethical and compliant behaviors in all aspects of the job.
13. Represent the company in a professional and positive manner at all times.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Raleigh, NC, USA is between $63,000 and $97,000 per year. This may vary depending on the specific industry and company the specialist is working for, as well as their level of experience and education.

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.