Vice President, Regulatory Affairs, CMC
Novato, CA or Brisbane, CA
Ultragenyx – Regulatory Affairs
Why Join Us?
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Come join our team during this exciting time of growth and opportunities!
We are headquartered in Novato, CA, 25 miles north of San Francisco, and we also have an office in Brisbane, CA, 10 miles south of San Francisco.
Ultragenyx is seeking a highly motivated VP or Executive Director, Regulatory Affairs CMC, who is a team builder and enjoys a fast paced, dynamic work environment. In this newly created position, this person will be responsible for leading the Regulatory Affairs CMC group and developing, implementing, and advising on global CMC regulatory strategies for new and late stage programs to secure and maintain market access for product(s) in line with business objectives, and in coordination with key internal 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 clinical studies and marketing approval in domestic and international markets, CMC regulatory strategic development plans and risk assessments, critical issue management and Health Authority interactions while ensuring that the latest 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 in order to plan, evaluate and recommend CMC regulatory strategy. Externally, the individual will interface with outside regulatory agencies and business partners in regards to CMC development, regulatory, and registration strategies. He/she will support/lead development and implementation of department policies. The individual will also maintain awareness of global regulatory environment and assess and communicate impact of changes on business and product development programs. This position will report to the Vice President of Regulatory Affairs.
Responsibilities, including but not limited to:
- Provides strategic and operational regulatory direction and mentorship on projects including, but not limited to general CMC regulatory strategies, regulatory requirements for clinical studies and marketing approval in domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and Health Authority interactions
- Uses 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
- Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise and the provision of appropriate resources
- Able to articulate complex Regulatory CMC issues and support global development and commercialization of early and late state programs
- Oversees and/or leads as necessary the preparation and submission of documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met
- Reviews CMC sections of IND/CTA, NDA/BLA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements
- Liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key CMC regulatory issues and to expedite approvals of product
- Maintains awareness of global regulatory environment and assesses impact of changes on business and product development programs. Facilitates policy and development of standard interpretation of global regulation
- Proactively manages critical CMC issues, taking leadership for the regulatory contribution
- Develops and implements department policies, processes and SOPs
- BA/BS Degree required, preferably in a health/life sciences or related field
- A minimum of 10 years in the biotechnology or pharmaceutical industry. Extensive experience in CMC Regulatory including IND/CTA, NDA/BLA/MAA, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, and developing and implementing complex CMC regulatory strategies
- Rare disease experience is desirable
- Business travel to be ~10-20% as required
Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability,marital and veteran status.
Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.