Senior Manager, Global Regulatory Labeling at Ultragenyx in Novato, CA

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:

ultradedicated – Your biggest challenges yield rare possibilities

The Senior Manager, GRA Global Labeling will be responsible for providing global labeling expertise and direction in support of the development, registration, and lifecycle management of innovative programs for rare diseases. This individual will liaise across key functional areas collecting critical regulatory milestones and developing detailed target label strategy plans during clinical development programs in order to align with company objectives and registration strategies. The responsibilities include managing labeling changes for lifecycle products, assisting in the development of labeling content for new products in pre-approval stages, and reviewing applicable regulatory documentation and artwork. The individual will also support implementation of approved labels which may include document control, QC/proofread, translations and verification of translations, and tracking project milestones and status.

The individual must possess a thorough knowledge of global regulations and guidances governing drugs and biologics in all phases of clinical development. This position will report to Senior Director, GRA Global Labeling.

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:

Provides global labeling leadership in support of the development, registration, and life-cycle management of Ultragenyx products for rare diseases.
Prepare new and revised labeling content (Company Core Data Sheet, Prescribing Information, Summary of Product Characteristics, Major Market labels, Patient Information, and Instructions for Use) based on source reports, regulatory requirements, and other reference sources.
Demonstrate the ability to work in a matrix environment communicating label concepts and key messaging during label development consistent with program strategy and understanding and educating the impact to downstream activities (i.e., for commercial, and promotional educational purposes).
Build strong collaboration with key internal stakeholders, including Global Regulatory leadership team, Clinical Development, Safety, Quality, Commercial, Medical Affairs, Legal, Manufacturing, Supply Chain, and other functions to support development of draft label text.
Interact with the cross functional labeling team (Label Working Group and Label Review Committee) to ensure timely implementation of global labeling changes in local product information that are consistent with the company’s position defined in the CCDS and in compliance with local labeling regulations.
Prepare, deliver and/or manage all types of regulatory documents/submissions influencing and managing cross-functional team member input to provide high quality deliverables that meet regulatory standards, and corporate and program milestones. Facilitate LWG/LRC/SME meetings to develop content for label documents including resolution of complex label issues and ability to drive consensus utilizing current standard operating procedures, best practices and/or work instructions including work requests associated with partner companies and vendors.
Facilitate and lead target label strategies with cross functional labeling team incorporating key messaging aligned with target product profile and thorough understanding of competitive landscape environment. Provide necessary label output for HA interactions (i.e., FDA/EMA/PMDA/HC briefing book, scientific advice, and/or other key submission readiness milestones).
Manage approved labels in a document label management system to ensure accurate and up-to-date labeling is always available and accessible for global submissions and inspection readiness.
Contribute to the review and approval of artwork supporting global submissions.
Implement and maintain a quality control measure during all stages of label development.
Maintain knowledgebase of current global rules, regulations, and relevant guidances (draft or final) governing drugs and biologics in all phases of development, as well as knowledge of therapeutic area(s).
Initiate or contribute to local and/or global process and/or system improvements which have a significant impact on business.

Requirements:

Minimum BA/BS degree in life sciences. Advanced degree preferred.
Strong scientific background with at least 6 years’ experience in the biotechnology and/or pharmaceutical industry including at least 3+ years in a global regulatory/labeling position.
Excellent attention to detail with solid coordinating, task planning and time management skills.
Excellent verbal, written and interpersonal communication skills.
Ability to work independently and in a team environment, with strong leadership, negotiation and influencing ability.
Strategic thinker and problem-solver capable of providing advice, identifying risks, decision making, and implementing plans and risk mitigation strategies.
Thorough understanding of global drug development regulations and guidelines.
Willingness to work in a dynamic and changing corporate environment. #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.

Pay Range$135,400—$167,300 USD 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 talentacquisition@ultragenyx.com.

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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: talentacquisition@ultragenyx.com.