Director, Global Regulatory Affairs Labeling

Ultragenyx Pharmaceutical Inc.; United States; Remote; USD 201,000 - 250,000; Full time

Job summary

A leading biotechnology company is seeking a Director for Global Regulatory Affairs Labeling to manage the labeling process for innovative treatments targeting rare diseases. The candidate will ensure compliance with regulations while collaborating with various departments to create effective labeling content and improve processes.

Benefits

Generous vacation time and public holidays

Long term incentive and Employee stock purchase plans

Fitness reimbursement

Qualifications

• Minimum of 8 years in biotech/pharma, with 5 years in regulatory/labeling.
• Ability to work independently and in teams.
• Thorough understanding of global drug development regulations.

Responsibilities

• Manage labeling for lifecycle products, including QC and regulatory documentation.
• Collaborate with internal stakeholders on label text development.
• Lead labeling strategy meetings and facilitate content development.

Skills

Attention to detail

Leadership

Strategic thinking

Problem-solving

Education

BA/BS in life sciences

Advanced degree preferred

Job description

Director, Global Regulatory Affairs Labeling

United States - Remote

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 andpersonally, come join our team.

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

The Director, GRA Global Labeling will be responsible for providing global labeling expertise anddirection in support of the development, registration, and lifecycle management of innovativeprograms for rare diseases. The responsibilities include managing labeling changes for lifecycleproducts, assisting in the development of labeling content for new products in pre-approvalstages, and reviewing applicable regulatory documentation and artwork. You will alsosupport implementation of approved labels which may include document control, QC/proofread,translations and verification of translations, and tracking project milestones and status. You will need a thorough knowledge of global regulations and guidance governing drugs and biologics in all phases of clinical development.

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-cyclemanagement of Ultragenyx products (bofor rare diseases).
• Prepare new and revised labeling content (Company Core Data Sheet, Prescribing Information,Summary of Product Characteristics, Major Market, Patient Information, and Instructions for Use)based on source reports, regulatory requirements, and other reference sources.
• 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 ReviewCommittee) to ensure timely implementation of global labeling changes in local productinformation that are consistent with the company’s position defined in the CCDS and incompliance with local labeling regulations.
• Provide critical review of label documents to ensure key messaging is consistent with program strategy.
• Facilitate LWG/LRC/SME meetings to develop content for label documents including resolution ofcomplex label issues and ability to drive consensus utilizing current standard operatingprocedures, best practices and/or work instructions.
• Facilitate and lead target label strategies with cross functional labeling team incorporating keymessaging aligned with target product profile and thorough understanding of competitivelandscape environment.
• 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 guidance (draft or final) governing drugs and biologics in all phases of development, as well as knowledge oftherapeutic area(s).
• Initiate or contribute to local and/or global process and/or system improvements.

Requirements:

• Minimum BA/BS degree in life sciences. Advanced degree preferred.
• A minimum of 8 years’ experience in the biotechnology and/or pharmaceutical industry including at least 5 years in a global regulatory/labeling position.
• Excellent attention to detail with solid coordinating, task planning and time management 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

$201,900 - $249,400 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

· Long term incentive and Employee stock purchase plans or equivalent offerings

· Fitness reimbursement

* 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 [e-mail] .

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:[e-mail] .

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