Regulatory Affairs Specialist

Welcome to Eli Lilly and Company, where we are committed to making life better for people around the world. We are currently seeking a highly motivated and detail-oriented individual to join our team as a Regulatory Affairs Specialist. In this role, you will play a crucial role in ensuring our products meet regulatory requirements and are safe for patients. As a Regulatory Affairs Specialist, you will have the opportunity to work with cross-functional teams and global regulatory agencies to bring life-changing medicines to market. We are looking for candidates with a strong background in regulatory affairs and a passion for improving patient outcomes. If you are driven, adaptable, and thrive in a fast-paced environment, we encourage you to apply for this exciting opportunity.

1. Collaborate with cross-functional teams to develop and implement regulatory strategies for new and existing products.
2. Ensure all regulatory submissions are completed accurately and in a timely manner.
3. Monitor and interpret changes in regulations and guidelines to ensure compliance.
4. Prepare and review regulatory documents, including submissions to global regulatory agencies.
5. Communicate with regulatory agencies to address any issues or inquiries related to submissions.
6. Participate in regulatory agency meetings and audits.
7. Contribute to the development and maintenance of regulatory policies and procedures.
8. Conduct regulatory compliance assessments and identify areas for improvement.
9. Coordinate and track product registrations, renewals, and variations.
10. Collaborate with internal teams to ensure product labeling and promotional materials are in compliance with regulations.
11. Provide regulatory guidance and support to other departments, including research and development and quality assurance.
12. Keep abreast of industry trends and changes in regulations to inform decision-making.
13. Participate in training and development programs to enhance regulatory knowledge and skills.
14. Maintain accurate and up-to-date records of all regulatory activities.
15. Represent the company in a professional and positive manner when interacting with regulatory agencies and external stakeholders.
16. Adhere to ethical and legal standards in all regulatory activities.
17. Prioritize tasks and manage workload to meet project deadlines.
18. Communicate effectively with team members and stakeholders to ensure alignment and progress on regulatory projects.
19. Identify and report any potential regulatory risks or issues to management.
20. Continuously seek opportunities to improve processes and procedures within the regulatory affairs function.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Charlotte, NC, USA is $70,000 to $100,000 per year. This may vary depending on the specific company, years of experience, and additional skills and qualifications 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.