Senior Director, Regulatory Affairs CMC

Position Summary:

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Ultragenyx is seeking a highly motivated Senior Director, Regulatory Affairs CMC, who is a team builder and enjoys a fast-paced, dynamic work environment. In this position, the SDIR will be responsible for developing, implementing, and advising on global CMC regulatory strategies for all development-stage programs and marketed products to secure and maintain market access for the products in line with business objectives, and in coordination with key internal and external stakeholders. This individual will provide leadership, high level strategic and operational regulatory direction and mentorship on projects including, but not limited to CMC regulatory strategies, CMC regulatory requirements for development programs and commercial products in domestic and global markets, CMC regulatory strategic development plans and risk assessments, critical issues management and Health Authority interactions while ensuring that the most current requirements, standards, and trends within the company and industry are met.

The individual has departmental and corporate level influence and acts as an advisor/liaison to senior management to plan, evaluate and recommend CMC regulatory strategy. Externally, the individual will interface with global regulatory agencies and business partners with regards to technical development, CMC regulatory, registration, and life-cycle management strategies. He/she will support/lead the development and implementation of department policies. The individual will maintain awareness of the global regulatory environment and assess and communicate the impact of changes on business, development programs, and commercial products. This position will report to the Executive Director of Regulatory Affairs CMC.

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.

Or

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

• Provide strategic and operational regulatory direction and mentorship on projects including, but not limited to CMC regulatory strategies, CMC regulatory requirements for development programs and commercial products in domestic and global markets, CMC regulatory strategic development plans and risk assessments, critical issues management and Health Authority interactions.
• Use extensive knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.
• Build partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.
• Articulate complex Regulatory CMC issues and support global development and commercialization of programs.
• Oversee the preparation and submission of documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met.
• Review CMC sections of IND/CTA, NDA/BLA/MAA, and other global submissions in support of clinical development, marketing applications, commercial product, and their amendments/supplements/variations in conformance with local regulatory requirements.
• Liaise and negotiate with global regulatory authorities as needed for all aspects related to drug development including resolution of key CMC regulatory issues and to expedite approvals of product.
• Maintain awareness of the global regulatory environment and assess the impact of changes on business, development programs, and commercial products.
• Facilitate policy and development of the standard interpretation of global regulations.
• Proactively manage critical CMC issues, taking leadership for the regulatory contribution.
• Develop and implement department practices, policies, processes, and SOPs.

Requirements:

• BA/BS in a scientific field of study with 15 years + of relevant experience working in Regulatory in the pharmaceutical/ biotech industry, including commercial experience in both small and large molecules and other modalities.
• Extensive experience in CMC Regulatory including IND/CTA, NDA/BLA/MAA, lifecycle management, interactions with Health Authorities, leading and managing regulatory/CMC teams, and developing and implementing complex CMC regulatory strategies.
• Strong business acumen and ability to make sound decisions that contribute positively to the business.
• Excellent verbal and written skills; ability to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to the internal and external stakeholders.
• Strong negotiation skills and ability to think creatively and develop creative solutions.
• Ability to prioritize and handle multiple projects simultaneously.
• Rare disease CMC regulatory experience is desirable. #LI-CS1