Associate Director, Global Regulatory Operations
Overview: Ultragenyx is seeking a highly motivated professional for the role of Associate Director of Regulatory Operations in the Regulatory Affairs Department. The Associate Director of Regulatory Operations will oversee all aspects of publishing efforts for multiple programs and supervise associates and managers within the publishing team. This position will contribute to software evaluations and participate in upgrades and implementation to support preparing compliant electronic submissions to Regulatory Agencies. The role reports to the Regulatory Operations Director and participates in developing Regulatory Operations processes (SOPs, work instructions, guidelines, templates) for preparing submissions and regulatory information management.
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.
Responsibilities
* Responsible for cross-functional team to deliver a sustainable process and technology solution through discussions on business process.
* 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.
* 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.
* Coordinate and electronically compile all components of reports for regulatory submissions, including Clinical reports, safety reports, briefing books and meeting materials and other complex documents that require compilation of multiple files.
* Prepare submission-ready final electronic documents utilizing industry-standard authoring, document management and publishing tools to ensure electronic submissions meet all required standards and technical requirements within specified timelines.
* Manage regulatory submission timelines in accordance with project plans. Maintain report publishing metrics, tracking information and inform project teams and management on real-time status of documents.
* May assist more senior department members with system implementation and upgrade activities.
* Prepare and maintain SOPs, work instructions and checklists related to templates, electronic document management, electronic submission processes, and archiving.
Requirements
* BS or BA in science/technology or an equivalent combination of education and experience preferred.
* A minimum of 10 years of proven experience in a Regulatory Operations role within the pharmaceutical or biotech industry.
* Expert knowledge of eCTD/non-eCTD, regulatory compliance, publishing and document management systems (e.g., Veeva Vault RIM, SharePoint, docuBridge).
* Expert knowledge of regulatory reporting requirements including ICH E23 Clinical report structure.
* Strong knowledge and experience of MS Word, Acrobat Professional and Advanced PDF Processing Tools (ISI ToolBox).
* Excellent understanding of structure of reports and submission documents.
* Excellent verbal and written communication skills, strong organizational and time management skills.
* Strong attention to detail with the ability to detect and correct errors/inconsistencies in various types of documents.
* Ability to prioritize and balance multiple tasks to accomplish department goals in a dynamic environment.
* Strong problem-solving skills on moderately complex problems related to streamlining department processes and technology used in submissions.
* Experience managing a team of direct reports including contractors supporting different aspects of Regulatory Operations.
Benefits
* Generous vacation time and public holidays observed by the company
* Volunteer days
* Long term incentive and Employee stock purchase plans or equivalent offerings
* Employee wellbeing benefits
* Fitness reimbursement
* Tuition sponsoring
* Professional development plans
* Benefits vary by region and country
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 talentacquisition@ultragenyx.com.
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Note: This description does not imply an offer of employment and is subject to change. All candidate activity and open positions are managed through our Human Resources Department.
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