Senior Manager, Regulatory Affairs, CMC
Novato, CA or Brisbane, CA
Ultragenyx – 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, CA, 10 miles south of San Francisco.
Ultragenyx is seeking a highly motivated Manager/Senior Manager who enjoys a fast paced, highly dynamic work environment to support the Regulatory Affairs CMC team.
This position will support and manage the global regulatory activities associated with the Chemistry, Manufacturing and Controls for clinical and commercial products. This position will provide input into the product strategy and to the direction provided to commercial and clinical teams. The Manager/ Senior Manager will be responsible for assuring that regulatory submissions are on time and of high quality.
The position level is dependent on experience and qualifications. This position will report to the Director Regulatory Affairs CMC.
Responsibilities, including but not limited to:
- Manage the compilation, review and approval of the CMC data package for regulatory dossiers and documents in various phases of clinical development, global marketing applications, and post-approval life cycle activities
- Ensure the CMC content is complete, well-written, and conforms with established requirements for regulatory submissions
- Work closely with and coordinate project related activities with Regulatory Operations to ensure appropriate regulatory support of projects
- As a Regulatory CMC representative to assigned product teams, collaborate with project teams to implement Ultragenyx regulatory strategies
- Communicate with internal and external customers to obtain required supporting documents and data for compilation of the CMC dossier in a timely manner that supports agreed upon project timelines
- Ensure and/or enhance regulatory compliance with respect to filing requirements for assigned compounds throughout development and the commercial life cycle
- Coordinate the task of drafting responses to CMC related questions from FDA or foreign health authorities per established process
- Evaluate proposed manufacturing changes for global impact to ongoing and existing filings, and provide a regulatory assessment and a submission strategy for optimal implementation of changes
- Research and interpret global CMC regulations and provide regulatory guidance to the project teams and functional groups
- Support the organization in maintaining a work environment focused on quality and that fosters learning, open communication, collaboration, integration, and teamwork
- BA/BS degree in life sciences in chemistry, molecular biology, or similar is required, advanced degree preferred
- 5-7 years of experience in Regulatory Affairs CMC in the pharmaceutical and/or biotechnology industry. Alternatively, 3 years pharmaceutical Regulatory CMC experience combined with 4+ years relevant pharmaceutical experience (e.g. Pharmaceutical Development, Analytical Development, Production, Quality Assurance or Quality Control)
- Prior success filing clinical trial applications, marketing applications, amendments, supplements, and variations for drugs and/or biologics within timelines is required; global submission experience is a plus
- Understanding of scientific principles and regulatory CMC requirements relevant to all stages of pharmaceutical drug development and manufacturing, process validation, analytical operations, compliance and documentation
- Thorough understanding of relevant drug development regulations and guidelines is essential.
- Manufacturing and/or QA/QC experience
- Experience in assessing post-approval changes is preferred
- Ability to deal with issues of critical importance, providing regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance
- RAC certification desired
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.