Senior Manager, Regulatory Affairs

Position Summary:

ultraimpact – Make a difference for those who need it most

Ultragenyx is seeking a highly motivated Senior Manager who enjoys a fast paced, highly dynamic work environment to join Global Regulatory Affairs team in Regulatory Strategy.

You will support and manage the global regulatory activities for clinical and commercial products. You You will be responsible for assuring that regulatory submissions are on time and of high quality.

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:

• Manage the compilation, review and approval of regulatory submissions for regulatory dossiers and documents in various phases of clinical development, global marketing applications, and post-approval life cycle activities.
• Ensure the 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 Strategist 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 regulatory dossiers 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. Develop constructive relations with internal functional groups and external organizations.
• Coordinate the task of drafting responses to Health Agency questions from FDA and/or global Health Agencies.
• 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 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.

Requirements:

• BA/BS degree in life sciences in chemistry, molecular biology, or similar is required, advanced degree preferred.
• 7+ years of experience in Regulatory Affairs in the pharmaceutical and/or biotechnology industry.
• 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.
• Thorough understanding of relevant drug development regulations and guidelines is essential.
• 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.
• Good judgement in elevating and communicating actual or potential issues to line management.
• RAC certification desirable but not mandatory.
• Experience working in a matrix environment and excellent people skills are required. #LI-CS1 #LI-Hybrid #LI-Remote