Job Description

Why Join Us?
Be a hero for our rare disease patients
At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.
Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.
If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.
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 also be contributing to software evaluations and participating in 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.
• Coordinates and electronically compiles 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.
• Prepares 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.
• Manages, in close collaboration with submission managers and Regulatory Affairs, regulatory submission timelines in accordance with project plans. Maintains report publishing metrics, tracking information and informs project teams and management on real time status of business-critical documents.
• May assist more senior department members with system implementation and upgrade activities.
• Prepares and maintains 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. #LI-CK1 #LI-Hybrid

Full Time employees across the globe enjoy a range of benefits, including, but not limited to:
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 us at .
See our .
See our .
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: .

Skills Required