Job Description

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

ultrafocused – Work together to fearlessly uncover new possibilities

Ultragenyx is seeking an experienced and highly motivated Associate Director, Regulatory Affairs (Clinical/Nonclinical Strategy), EMEA who is a team player and enjoys a fast paced, dynamic work environment. The Associate Director will be responsible for developing key EMEA regulatory strategies and executing submissions while monitoring and assessing EMEA regulations including Gene Therapy guidance and regulation changes.This position will report to the Senior Director Regulatory Affairs EMEA

Work Model:

Flex: This role will typically require onsite work 2 days each week, depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

1. Interfaces with EMEA regulatory agencies as appropriate on select programs.
2. Independently research options for regulatory strategies and presents recommendations at regulatory sub teams and to leadership.
3. Represent EMEA Regulatory in sub team meetings, serving as the point of contact for the assigned products in the EMEA region, and interfacing with functional areas including Research, Development and Clinical in strategic development for early and late-stage products.
4. Provide regulatory guidance for the EMEA region and input throughout product development to the regulatory sub team.
5. Lead cross functional teams in EMEA Regulatory Filings (e.g. CTAs, GMOs, MAAs)
6. Lead selects Regulatory vendor meetings in alignment with product programs and Regulatory-driven projects
7. Maintain CTAs ensuring Agency compliance
8. Review clinical documentation, including protocols, DSUR’s, Investigator Brochures, Investigator Packages and General Investigational Plans to ensure GCP and Agency compliance
9. Lead teams in the development of briefing documents for EMEA Agency meetings
10. Manage and direct contractors/vendors as needed on programs
11. Keep current with EMEA Agency guidelines and regulations
12. Prepare comments on draft documentation sent out for consultation from the health authority
13. Contribute to creation of local labels as needed
14. Coordinate submission schedule with Publishing, ensuring delivery of high-quality documents
15. Participate on cross-functional committees and sub-teams in accordance with company initiatives, as necessary
16. Provides supervision and mentoring to junior regulatory professionals on the team, if applicable

Requirements:

1. BA/BS in a scientific field of study or BA/BS in another field of study and 8 years of relevant experience working in Regulatory in the pharmaceutical/ biotech industry, including preferred experience with Gene Therapies and other compounds for the treatment of rare diseases
2. Strong knowledge and experience in interpretation of EMEA regulations and guidelines related to drug development
3. In depth understanding and application of industry standards and international regulations and guidelines.
4. Experience in communicating regulatory strategy, submission documents and plans both internally and externally
5. The desire and ability to work in a fast-paced, start-up environment
6. Strong collaboration, teamwork, organizational skills at attention to detail
7. Requires initiative, creative problem-solving ability and excellent verbal and written communication skills

#LI-CK1 #LI-Hybrid

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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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 talentacquisition@ultragenyx.com