Director, Regulatory Affairs – EU

Role Overview

• Lead and Support European and global regulatory strategy support for the Business Units and support Business Development with new RFPs and regulatory strategies for device and drug development and clinical investigations
• European and global support of the strategy teams at the Business Units to develop a Regulatory and Startup strategy for new device, drug and combination products focused on RFPs and Projects
• Developing regulatory documents and leading support for EMA and European national scientific advice / protocol assistance meetings
• Lead and support regulatory development support activities including Pediatric Investigation Plans, Orphan Designation and other designations/support (e.g., PRIME)
• Regulatory Support of capabilities and bid defense meetings

Requirements

• Advanced degree in Life Sciences, Pharmacy, Medicine, or a related field
• Significant experience in regulatory affairs within pharmaceutical, biotechnology, or CRO environments
• Strong knowledge of European regulatory requirements and experience with EMA and national authorities
• Proven ability to lead regulatory strategy and work effectively with cross-functional and global teams
• Excellent communication, organizational, and problem-solving skills

Benefits

• Opportunities for personal and professional growth
• Collaboration, quality, and making a difference in patients' lives
• Core values of Trust, Quality, Passion, Flexibility, and Sustainability