Director, Regulatory Affairs – EU

This is a fully remote position, open to applicants in Spain.

📋 Description

• Provide leadership and support for European and global regulatory strategy initiatives for the Business Units, as well as assist Business Development with new RFPs and regulatory strategies pertaining to device and drug development and clinical investigations.

• Offer European and global assistance to the strategy teams within the Business Units in formulating a Regulatory and Startup strategy for new device, drug, and combination products, with a focus on RFPs and Projects.

• Create regulatory documents and lead efforts for EMA and European national scientific advice/protocol assistance meetings.

• Oversee and support regulatory development activities, including Pediatric Investigation Plans, Orphan Designation, and other designations/support (e.g., PRIME).

• Provide regulatory support for capabilities and during bid defense meetings.

⛳️ Requirements

• Possess an advanced degree in Life Sciences, Pharmacy, Medicine, or a related discipline.

• Have substantial experience in regulatory affairs within pharmaceutical, biotechnology, or CRO settings.

• Demonstrate strong knowledge of European regulatory requirements along with experience working with EMA and national authorities.

• Exhibit a proven ability to lead regulatory strategy and collaborate effectively with cross-functional and global teams.

• Possess excellent communication, organizational, and problem-solving skills.

🏝️ Benefits

• Opportunities for personal and professional growth.

• Engage in collaboration, quality initiatives, and contribute to making a difference in patients' lives.

• Uphold core values of Trust, Quality, Passion, Flexibility, and Sustainability.