Manager, Regulatory Affairs at Ultragenyx in Brisbane, 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:

ultrafocused – Work together to fearlessly uncover new possibilities

The Manager, Regulatory Affairs, is an individual contributor who will coordinate regulatory deliverables and interactions for select programs and will assist in developing regional regulatory strategies.

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.

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

With appropriate guidance, this role will support contact with Health Authorities on select programs.
Represent Regulatory in appropriate sub team meetings, serving as the point of contact for the assigned products, and interfacing with functional areas including Research, Development and Clinical in strategic development for early and late stage products.
Provide regulatory guidance and input throughout product clinical development to
Lead cross functional teams in Regulatory Filings (e.g. INDs, BLAs, CTAs, MAAs)
Maintain INDs/CTAs ensuring Agency compliance
Drive submissions on select programs
Review clinical documentation, including protocols, DSUR’s, Investigator Brochures, Investigator Packages and General Investigational Plans to ensure GCP and Agency compliance
Lead teams in the development of briefing documents for Agency meetings
Manage and direct contractors/vendors as needed on programs
Keep current with Agency guidelines and regulations
Prepare comments on draft documentation sent out for consultation from the health authority
Contribute in creation of local labels as needed
Coordinate submission schedule with Publishing, ensuring delivery of high quality documents
Author and contribute to departing operating procedures and work instructions

Requirements:

BA/BS in a scientific field of study or BA/BS in another field of study and 4-6 years of relevant experience working in Regulatory in the pharmaceutical/ biotech industry
Strong knowledge and experience in interpretation of regulations and guidelines related to drug development
In depth understanding and application of industry standards and international regulations and guidelines.
Experience in communicating regulatory strategy, submission documents and plans both internally and externally
The desire and ability to work in a fast-paced, start-up environment
Strong collaboration, team work, organizational skills at attention to detail
Excellent written and verbal communication 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$138,000—$170,400 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 · 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.

See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy. 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.