Heidi Arp-Nielsen

Sr. Regulatory Affairs Specialist

Heidi has more than 20 years of experience working with global regulatory affairs in the pharma industry. She is a skilled project manager, who has coordinated a broad variety of EU procedures (incl. CP, MRP, Orphan Drug Designation, Referral procedure) and contributed to the approval of several MAAs and BLAs.

In the role of RA CMC Lead for different biotech companies, Heidi has successfully developed and executed regulatory strategies for both development projects and mature products. Heidi has over the years written and reviewed numerous CMC documents incl. drug-device combination product documentation.