Regulatory Affairs Specialist-Principal

Are you a highly motivated and detail-oriented professional with a passion for ensuring compliance and patient safety? Look no further! Baxter International is seeking a Regulatory Affairs Specialist-Principal to join our dynamic team. As a global leader in healthcare, we are dedicated to improving the lives of patients around the world. In this role, you will have the opportunity to utilize your expertise in regulatory affairs to help bring life-saving products to market. If you have a strong background in regulatory compliance and a desire to make a difference, we want to hear from you! Join us in our mission to save and sustain lives.

1. Develop and implement regulatory strategies to ensure compliance with local, national, and international regulations for all products manufactured and distributed by Baxter International.
2. Conduct thorough research and analysis of regulatory requirements and communicate updates and changes to relevant departments.
3. Review and approve product labeling, marketing materials, and promotional activities to ensure compliance with regulatory standards.
4. Serve as the primary point of contact for regulatory agencies and participate in regulatory inspections and audits.
5. Maintain up-to-date knowledge of industry regulations and trends, and advise management on potential impacts and opportunities.
6. Collaborate with cross-functional teams to ensure timely submission and approval of regulatory documents and filings.
7. Review and assess product complaints and adverse events, and provide guidance on reporting requirements.
8. Monitor and track regulatory submissions and approvals, and maintain accurate records and documentation.
9. Assist in the development and maintenance of standard operating procedures and policies related to regulatory affairs.
10. Train and educate colleagues on regulatory requirements and best practices to ensure company-wide compliance.
11. Continuously evaluate and improve regulatory processes and procedures to enhance efficiency and effectiveness.
12. Represent Baxter International at industry conferences, meetings, and events to stay informed of industry developments and share knowledge and expertise.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist-Principal in Skaneateles Falls, NY, USA is $130,000 to $150,000 per year. This may vary based on the specific job responsibilities, level of experience, and the company's industry and size. It is important to note that salaries may also include bonuses and other benefits.

Baxter International Inc. is a Fortune 500 American health care company with headquarters in Deerfield, Illinois. The company primarily focuses on products to treat hemophilia, kidney disease, immune disorders and other chronic and acute medical conditions.