Senior Manager, Regulatory Affairs
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, just south of San Francisco.
The Senior Manager, Regulatory Affairs will be responsible for managing regulatory activities (clinical and post-marketing) to support a monoclonal antibody program for rare metabolic bone diseases. The responsibilities include working closely with cross functional teams to prepare regulatory submission timelines and co-ordinate submission content, preparing some components as appropriate, and managing the overall submission process including review and approval activities. . The individual must possess a sound knowledge of global regulations and guidances governing drugs and biologics in all phases of development.Strong communication, teamwork and organization skills are required.
Responsibilities, including but not limited to:
- Prepare/coordinate/file/manage the clinical content of submissions related to IND/CTAs/BLA, annual reports, and information amendments in multiple countries
- Act as the primary liaison with FDA for regulatory submissions
- Lead the preparation of responses to questions from Regulatory Authorities
- Interface with functional areas to identify and obtain information required for regulatory submissions
- Develop and/or review regulatory documents to ensure that all submissions are of high quality
- Create and maintain regulatory timelines and track deliverables to timelines to ensure regulatory submission timelines are met
- Participate in the development of regulatory strategies
- Proactively identify project issues and implement appropriate regulatory strategies to mitigate risks
- 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
- Manage direct reports as assigned
- Maintain knowledge of current global rules, regulations, and guidances governing development of drugs and biologics in all phases of development
- BA/BS degree in life sciences
- Strong scientific background with at least six (6)years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries.
- Excellent attention to detail with excellent coordinating, task planning and time management skills.
- Sound understanding of global drug/biologics regulations and guidelines.
- Proven ability to successfully manage submissions and projects to deadlines.
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.