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

The Senior Director, Regulatory Affairs will be responsible for providing global regulatory leadership and direction in support of the development, registration, and life-cycle management of innovative programs for rare diseases. The responsibilities include developing regulatory strategies and detailed plans to ensure successful achievement of company objectives, participating in program core teams and governance forums, and managing regulatory agency interactions in support of development and registration strategies. The individual will provide oversight of the content and preparation of all regulatory documents/submissions related to applicable programs and mentor junior members of the regulatory team. The individual must possess a thorough knowledge of global rules, regulations, and guidances governing drugs and biologics in all phases of development. This position will report to Vice President, Regulatory Affairs (clinical/nonclinical strategy).

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 regulatory leadership in support of the development, registration, and life-cycle management of Ultragenyx products (both early-stage and late-stage development) for rare diseases.
Provides strategic regulatory direction on programs to support the global regulatory plan, development plans/clinical study designs, risk assessments, critical issue management and Health Authority interactions. Represents Regulatory on Program Core Teams as applicable. Leads regulatory sub-teams as required.
Liaises and negotiates with global regulatory agencies (e.g. FDA, EMA, Health Canada) as needed for all aspects pertaining to drug development including novel regulatory pathways for the company’s rare disease products, resolution of key regulatory issues and to expedite approvals of products.
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.
Provide critical review of documents related to clinical and nonclinical aspects of programs to ensure messaging is consistent with program strategy.
Maintain knowledge of and monitor changes in current global rules, regulations, and guidances 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 improvements which have a significant

Requirements:

Minimum BA/BS degree in life sciences. Advanced degree preferred.
Strong scientific background with at least twelve (12) years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries.
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.
Proven ability to successfully manage major submissions and critical projects to deadlines.
Proven ability to successfully interact with regulatory authorities.
Experience in the preparation and filing of marketing applications is highly desirable
Experience with development of drugs/biologics for rare diseases is preferred.

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

$234,900—$290,200 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.

Senior Director, Regulatory Affairs

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