Vice President, Regulatory Affairs, CMC

Position Summary:

ultrafocused - Work together to fearlessly uncover new possibilities

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.

Work Model:

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

• Lead the Regulatory CMC function to support the CMC portfolio goals with proven track record of successfully building and leading teams.

• Lead global CMC regulatory strategies for projects in development and marketed products, including risk mitigation strategies to ensure approvals and maintenance of product licenses.

• Strengthen internal gene therapy CMC capability by working with internal stakeholders and external partners to evaluate and enable gene therapy related GTP/GMP facility

• Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.

• Exercise expertise in the interpretation and implementation of ICH guidelines with a goal of an approved/ harmonized regulatory control strategy.

• Ensure regulatory conformance & consistency for assigned products globally in compliance with regulatory requirements and internal procedures.

• Partner across the CMC functions in the company, and other functional groups at Ultragenyx to support opportunities for regulatory innovation / promote the use of novel approaches within project teams to resolve issues and problems.

• Develop meaningful and collaborative relationships with local & global internal/ external partners.

• Demonstrate success in influencing without positional authority within a highly matrixed organization.

Requirements:

• 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