Associate Director, Regulatory Affairs

Summary

Join Ultragenyx as an Associate Director, Regulatory Affairs (Clinical/Nonclinical Strategy), EMEA and play a pivotal role in developing and executing key EMEA regulatory strategies. You will lead regulatory submissions, monitor EMEA regulations (including Gene Therapy guidance), and represent EMEA Regulatory in sub-team meetings. This position requires strong collaboration with internal teams and external agencies. The role offers a flexible work model (Flex or Remote) and the opportunity to contribute to the development of life-changing treatments for rare diseases. You will provide regulatory guidance, lead cross-functional teams in regulatory filings, and mentor junior regulatory professionals. Ultragenyx offers a supportive and inclusive work environment with a range of benefits.

Requirements

• 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
• Strong knowledge and experience in interpretation of EMEA 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, teamwork, organizational skills at attention to detail
• Requires initiative, creative problem-solving ability and excellent verbal and written communication skills

Responsibilities

• Interfaces with EMEA regulatory agencies as appropriate on select programs
• Independently researches options for regulatory strategies and presents recommendations at regulatory sub teams and to leadership
• 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
• Provide regulatory guidance for the EMEA region and input throughout product development to the regulatory sub team
• Lead cross functional teams in EMEA Regulatory Filings (e.g. CTAs, GMOs, MAAs)
• Lead select Regulatory vendor meetings in alignment with product programs and Regulatory-driven projects
• Maintain CTAs ensuring Agency compliance
• 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 EMEA Agency meetings
• Manage and direct contractors/vendors as needed on programs
• Keep current with EMEA Agency guidelines and regulations
• Prepare comments on draft documentation sent out for consultation from the health authority
• Contribute to creation of local labels as needed
• Coordinate submission schedule with Publishing, ensuring delivery of high-quality documents
• Participate on cross-functional committees and sub-teams in accordance with company initiatives, as necessary
• Provides supervision and mentoring to junior regulatory professionals on the team, if applicable

Benefits

• 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