Vice President, Regulatory Affairs, CMC

Job Description

• The Vice President of CMC Regulatory Affairs is leading the Ultragenyx’s CMC Regulatory Affairs function. • Ultragenyx have an exciting portfolio with both marketed, late and early-stage projects across Gene Therapy, Biologics and small molecules for Rare Diseases. • This position is a key strategic role ensuring regulatory strategies supports global approvals and maintains our global licenses across North America, Europe, Latin America and Japan. In addition, the leader will be recognized as a global thought leader for regulatory science and be accountable for leading the interpretation and implementation of CMC regulatory guidelines, regulations and current environment to assure approvability in high priority regions. • The leader will also be responsible for ensuring that regulatory strategy is deeply integrated into Pharmaceutical Development & Manufacturing (PDM) project teams and overall goals. The role will report directly to Senior Vice President of Regulatory Affairs at Ultragenyx.

Qualifications

• A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD. • Demonstrated organizational leadership skills at both functional and enterprise levels. • Experience with leading NDA/BLA submission and approvals including global Health Authority Interactions. • Application of sound and accurate judgment to make timely decisions. • Gene Therapy experience is preferable. • Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.). • Demonstrated success in leading complex groups to support operational goals and contribute to the development of global regulatory initiatives. • Excellent strategic acumen, collaboration, and communication skills are required. #LI-CS1 #LI-Hybrid

Benefits

• Generous vacation time and public holidays observed by the company • Volunteer days • Long term incentive and Employee stock purchase plans or equivalent offerings • Employee wellbeing benefits • Fitness reimbursement • Tuition sponsoring • Professional development plans