Regulatory Affairs Specialist

Welcome to Eli Lilly and Company, where we are dedicated to discovering and delivering innovative medicines that make life better for people around the world. We are currently seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring that our products comply with all applicable regulatory requirements. Our ideal candidate has a strong understanding of regulatory guidelines and a passion for improving and protecting public health. If you are ready to make a meaningful impact and contribute to the success of our company, we encourage you to apply for this exciting opportunity.

1. Ensure compliance with all relevant regulatory requirements for our products.
2. Stay up-to-date with changes in regulatory guidelines and communicate updates to internal stakeholders.
3. Prepare and submit necessary regulatory documents to authorities for product approvals.
4. Collaborate with cross-functional teams to support product development and registration process.
5. Conduct thorough research and provide recommendations on regulatory strategies.
6. Review and approve product labeling and promotional materials to ensure compliance with regulations.
7. Respond to regulatory inquiries and requests from authorities.
8. Maintain accurate and up-to-date records of all regulatory submissions and approvals.
9. Participate in internal and external audits to ensure compliance with regulations.
10. Provide guidance to internal teams on regulatory requirements and processes.
11. Identify and escalate potential regulatory risks or issues.
12. Continuously monitor and assess changes in the regulatory landscape and provide recommendations for adaptation.
13. Collaborate with global regulatory teams to ensure consistency and alignment with international regulations.
14. Participate in meetings with regulatory authorities to discuss product submissions and approvals.
15. Support the development and maintenance of regulatory policies and procedures.
16. Act as a subject matter expert on regulatory requirements and provide training and guidance to colleagues.
17. Contribute to the overall success of the company by actively participating in company initiatives and projects.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Columbus, OH, USA is typically between $61,000 and $91,000 per year. However, this range can vary depending on factors such as experience, education, and the specific industry or company the specialist is working in. Salaries may also be higher in larger companies or in industries with high demand for regulatory affairs professionals.

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.