Regulatory Affairs Specialist

Are you a detail-oriented, organized individual with a passion for ensuring compliance in the pharmaceutical industry? Look no further than our Regulatory Affairs Specialist position at Eli Lilly and Company. As a global leader in the healthcare industry, we are seeking a highly skilled and experienced professional to join our team. In this role, you will play a critical role in ensuring that our products meet all regulatory requirements and maintain the highest standards of quality and safety. If you have a strong understanding of regulatory guidelines and a proven track record of success in this field, we encourage you to apply for this exciting opportunity.

1. Ensure compliance with all relevant regulatory guidelines and requirements for pharmaceutical products.
2. Conduct thorough research and analysis of current and upcoming regulatory policies and changes.
3. Develop and maintain a deep understanding of the pharmaceutical industry and its regulatory landscape.
4. Collaborate with internal teams to ensure all products meet regulatory requirements and standards.
5. Prepare and submit regulatory submissions, including new drug applications, amendments, and annual reports.
6. Review and approve labeling, packaging, and promotional materials to ensure compliance with regulatory guidelines.
7. Maintain accurate and up-to-date records of all regulatory documentation and submissions.
8. Communicate with regulatory agencies as necessary and respond to any inquiries or requests for information.
9. Conduct internal audits to ensure compliance with regulatory guidelines and identify areas for improvement.
10. Provide guidance and training to other team members on regulatory requirements and best practices.
11. Stay informed about industry trends and developments in order to anticipate and adapt to changes in regulatory requirements.
12. Continuously monitor and assess company processes to identify and address any potential compliance issues.
13. Participate in cross-functional teams to support the development and launch of new products.
14. Maintain confidentiality and adhere to ethical standards when handling sensitive information.
15. Represent the company in a professional manner during regulatory inspections and audits.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Milwaukee, WI, USA is $65,000 - $85,000 per year. This may vary depending on the specific company, experience level, and education 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.