Director, Regulatory Affairs Policy and Intelligence 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:

We are seeking a proactive and strategic Regulatory Policy & Intelligence professional to support our mission to bring transformative therapies to patients with rare diseases. This role will monitor global regulatory trends, assess their impact on our pipeline, and help shape the regulatory landscape by engaging with policy-setting bodies and industry groups.

The ideal candidate will bring deep knowledge of global regulatory systems (FDA, EMA, etc.), a strong understanding of rare drug development, and the ability to translate evolving regulations into actionable insights for cross-functional teams.

ultrainnovative – Tackle rare and dynamic challenges

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:

Regulatory Intelligence

Monitor and analyze global regulatory developments (laws, guidelines, precedents) relevant to rare diseases, cell/gene therapy, and orphan drug designations

Maintain a real-time intelligence database or dashboard for internal stakeholders

Conduct competitor landscape analyses on regulatory strategies and product approvals

Regulatory Policy

Shape external policy through active engagement with regulatory bodies, trade associations, and working groups (e.g., BIO, NORD, EFPIA)

Draft and coordinate company responses to regulatory consultations and guidance documents

Represent the company in industry policy forums and public-private initiatives

Strategic Advising

Advise internal stakeholders (clinical, regulatory, legal, CMC, etc.) on the impact of regulatory changes

Support strategy development for interactions with health authorities (e.g., pre-IND, scientific advice, PRIME/BREAKTHROUGH designation requests)

Identify opportunities for accelerated pathways and incentives (e.g., Orphan Drug Designation, RMAT, Priority Review, PIP/waivers in the EU)

Internal Education & Communication

Create and deliver briefings, newsletters, and training sessions on emerging regulatory trends

Act as a liaison between regulatory policy and therapeutic area leads, providing policy impact assessments tailored to program needs

Requirements:

Advanced degree preferred (PhD, PharmD, MD, MS in life sciences); Bachelor’s with strong experience also considered

8–10 years of experience in regulatory affairs, policy, or intelligence roles in biotech/pharma

Strong knowledge of rare disease regulatory pathways and designations (FDA Orphan Drug, EMA PRIME, etc.)

Demonstrated experience in interpreting and applying global regulatory policy

Excellent communication, collaboration, and strategic thinking skills

#LI-CS1 #LI-Hybrid
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$225,300—$278,300 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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