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 in the company!
Ultragenyx is headquarted in Novato, CA (25 miles north of San Francisco) and we also have an office in Brisbane, CA.
Ultragenyx is seeking a highly motivated Associate Director, Regulatory Affairs CMC, who is a team player and enjoys a fast paced, dynamic work environment. The Associate Director, Regulatory Affairs is a position in a newly created Regulatory CMC group devoted to developing regulatory CMC strategies and supporting rapid development of products targeting ultra-rare indications. He/she will be responsible for managing the regulatory CMC aspects of assigned projects in early to late stage development, which includes ensuring that global regulatory requirements for clinical studies and registrations in domestic and international markets are met.
The position level is commensurate with experience and qualifications.
• Manage regulatory CMC aspects of assigned development projects by developing regulatory strategic development plans, risk assessments and CMC regulatory strategies, and interacting with global Health Authorities.
• Participate in the development of regulatory strategy and provide strategic input and regulatory advice to the project teams on development programs.
• Proactively identify project CMC issues and implement appropriate regulatory strategies to mitigate risks.
• Create and maintain regulatory timelines and track deliverables to timelines to ensure submission timelines are met for assigned projects.
• Interface with functional areas (primarily CMC) to identify and obtain information required for regulatory submissions.
• Provide critical review of documents (SOPs, protocols and reports, etc.) related to chemistry, manufacturing, and controls, as necessary.
• Manage the preparation and filing of regulatory applications (IND/CTA, NDA/BLA/MAA, annual reports, etc.) and any post-marketing commitments. Develop and/or review regulatory documents to ensure that all submissions are of high quality.
• Interface with global regulatory authorities and consultants, as needed.
• Support the preparation and conduct of Agency meetings as necessary to support regulatory filings and applications, including preparation and coordination of briefing packages.
• Maintain knowledge of current global regulations and guidance governing drugs and biologics in all phases of development.
• BA/BS degree in life sciences or experience in drug development. Advanced degree is preferable.
• Strong scientific background with at least seven (7) years of experience in Regulatory Affairs CMC in the biotechnology or pharmaceutical industry.
• Experience with development and/or post-marketing of drugs and/or biologics is required.
• Strategic thinker and problem-solver capable of providing advice, identifying risks, making informed decisions, and implementing plans and risk mitigation strategies.
• Thorough understanding of global drug development regulations and guidelines.
• Experience in managing, mentoring and developing direct reports
• Ability to work independently and in a team environment, with strong leadership, negotiation and influencing ability.
• Proven ability to successfully manage major submissions and critical projects to deadlines.
• Proven ability to successfully interact with regulatory authorities.