Senior Regulatory Affairs Director
5 days ago
Estimated Annual Salary: $120,000 - $180,000
About ICON plcWe are a world-leading healthcare intelligence and clinical research organization dedicated to fostering an inclusive environment that drives innovation and excellence.
At ICON, we are committed to shaping the future of clinical development by collaborating with talented professionals who share our passion for advancing innovative treatments and therapies.
Key Responsibilities:- Lead Regulatory Operations: Oversee regulatory operations activities to ensure compliance with applicable regulations and guidelines.
- Develop Regulatory Strategies: Design and implement strategies for regulatory submissions and approvals, including INDs, NDAs, BLAs, and marketing authorization applications.
- Cross-Functional Collaboration: Provide regulatory guidance and support throughout the drug development process by working closely with cross-functional teams.
- Regulatory Submissions: Manage regulatory submissions and timelines, ensuring accuracy and completeness of documentation.
- Education: Bachelor's degree in a scientific or related field; advanced degree preferred.
- Experience: 8+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Global Regulatory Knowledge: Strong understanding of global regulatory requirements and guidelines.
- Leadership Experience: Proven track record of successful regulatory submissions and approvals, along with proven leadership experience.
- Competitive Salary: Earn a competitive salary that reflects your skills and experience.
- Diverse Benefits Package: Enjoy a range of benefits, including annual leave entitlements, health insurance options, retirement planning opportunities, and employee assistance programs.
- Professional Growth: Take advantage of opportunities for professional growth and development within a dynamic and inclusive work environment.
Lifelancer is a talent-hiring platform connecting professionals with exciting opportunities in pharma, biotech, health sciences, and IT domains. Apply now and explore similar roles on our platform.
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