Regulatory Affairs Specialist

Are you passionate about ensuring the safety and effectiveness of pharmaceutical products? Do you have a strong understanding of regulatory compliance and a keen eye for detail? If so, Eli Lilly and Company has an exciting opportunity for you as a Regulatory Affairs Specialist. We are seeking a highly skilled and motivated individual to join our team and play a crucial role in obtaining and maintaining regulatory approvals for our life-saving medications. As a Regulatory Affairs Specialist, you will be responsible for navigating complex regulatory requirements and collaborating with cross-functional teams to bring innovative treatments to patients. If you have a strong background in regulatory affairs and a desire to make a meaningful impact in the healthcare industry, we encourage you to apply for this position.

1. Monitor and stay up-to-date on relevant laws, regulations, and guidelines related to pharmaceutical products.
2. Work closely with cross-functional teams to develop and execute regulatory strategies for new and existing products.
3. Prepare and submit regulatory applications, including new drug applications, biologic license applications, and marketing authorization applications.
4. Ensure compliance with regulatory requirements for labeling, advertising, and promotional materials.
5. Conduct thorough reviews of product data and documentation to ensure accuracy and completeness.
6. Communicate and negotiate with regulatory authorities to obtain and maintain product approvals.
7. Serve as a subject matter expert on regulatory requirements and provide guidance and training to internal teams.
8. Develop and maintain strong relationships with regulatory agencies and represent the company during regulatory inspections.
9. Monitor post-approval activities and ensure timely reporting of any changes or updates to regulatory authorities.
10. Participate in the development and implementation of company policies and procedures related to regulatory compliance.
11. Collaborate with other departments to ensure that all processes and procedures are in line with regulatory requirements.
12. Keep track of timelines and deadlines for regulatory submissions and ensure timely completion.
13. Conduct risk assessments and provide recommendations for mitigating potential compliance issues.
14. Continuously evaluate and improve processes and procedures to ensure compliance with changing regulations.
15. Act as a liaison between the company and regulatory authorities, responding to inquiries and providing necessary information and documentation.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Seattle, WA, USA is between $80,000 and $120,000 per year. This may vary depending on the specific company, industry, and level of experience.

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.