Senior Director, Regulatory Operations
Ultragenyx Pharmaceutical Inc.
Position Summary:
ultrainnovative – Tackle rare and dynamic challenges
Ultragenyx is seeking a technically savvy, highly collaborative Senior Director of Submission Operations to join our Global Regulatory Operations (GRO) team within the Global Regulatory Affairs (GRA) function. Reporting into the Vice President of Regulatory Operations, this role demands a fully engaged, results-driven leader that’s dedicated to executing our global regulatory submission strategies while upholding the highest standards of compliance and quality.
Work Model:
Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.
Responsibilities:
- Operational Excellence: Lead the successful execution of compliant, high-quality regulatory submissions and services that align with business priorities. Ensure that all submission activities strictly adhere to regulatory requirements and company standards, driving operational efficiency.
- Regulatory Expertise: Maintain comprehensive expertise in global filing requirements, including FDA, EMA, CA, MHRA and other health authorities. Utilize in-depth knowledge of drug development processes and functional interdependencies to inform and enhance submission dossier support strategies across the business.
- Leadership & Team Management: Champion the Submission Operations team by cultivating a culture of excellence, collaboration, and continuous improvement. Inspire and empower team members to realize their full potential through effective mentorship and professional development initiatives.
- Stakeholder Influence: Build and nurture strong relationships with key stakeholders, effectively communicating submission strategies and garnering support for initiatives. Influence critical decisions by presenting compelling, data-driven insights and strategic recommendations.
- Innovative Problem-Solving: Challenge conventional practices and proactively seek process enhancements. Use innovative thinking to refine end-to-end submission processes, strengthen core capabilities, and elevate overall performance.
- Adaptability in a Fast-Paced Environment: Proven ability to thrive in dynamic settings by effectively managing multiple priorities and overlapping deadlines. Skilled in assessing emerging industry trends and integrating best practices into team operations to enhance efficiency and drive results.
Requirements:
- Bachelor's degree in life sciences, technology, or a related field.
- Over 10 years of professional regulatory operations experience, ideally in a global environment, including a minimum of 5 years in a leadership role.
- Engagement, management, and oversight of external service and resource suppliers that support global operations.
- Expert knowledge of eCTD/non-eCTD, regulatory compliance, publishing and document management systems (e.g., Veeva Vault RIM, SharePoint, docuBridge).
- In-depth understanding of global regulatory requirements (e.g., FDA, EMA, ICH) and emerging health authority initiatives and standards with ability to assess impact, communicate, and update and/or mobilize change, to support business objectives.
- Proven success in managing multiple complex global submissions, developing performance metrics, and driving process improvements.
- Exceptional communication and interpersonal skills, with the ability to engage and influence stakeholders at all levels.
- Excellent analytical and problem-solving abilities, with a keen eye for detail. #LI-CS1 #LI-Remote
The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.