Associate Director, Global Regulatory Operations
Position Summary:
ultrainnovative – Tackle rare and dynamic challenges
Ultragenyx is seeking a highly motivated individual 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 of multiple programs and will supervise associates and managers within the publishing team. This position will contribute to software evaluations, upgrades and implementation in support of preparing compliant electronic submissions to Regulatory Agencies. This position will report to and work closely with the Regulatory Operations Director and participate in the development of 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 business-critical 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 at least 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.
* Must have excellent verbal and written skills, strong organizational and time management skills.
* Must have a strong attention to detail with an ability to detect and correct errors/inconsistencies in various types of documents.
* Must be able to assist management in prioritizing and balancing multiple tasks to accomplish department goals.
* Must possess flexibility to work effectively within an environment that has quickly changing processes, priorities and deadlines.
* Must have strong problem-solving skills on moderately complex problems in relation to streamlining department processes and technology used in relation to submissions.
* 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
Equal Opportunity: 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.
Contact: See our Privacy Notice and Privacy Policy for details. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Please contact talentacquisition@ultragenyx.com for inquiries regarding recruiting relationships.
Seniority level
* Director
Employment type
* Full-time
Job function
* Business Development and Sales
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