Associate Director, Regulatory Affairs, EMEA

<div class="content-intro"><div><strong>Why Join Us?</strong></div> <div> </div> <div><em>Be a hero for our rare disease patients</em></div> <div><em> </em></div> <div>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. </div> <div> </div> <div>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.</div> <div> </div> <div>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<em>. </em></div></div><h3 style="text-align: left;"><strong>Position Summary:</strong></h3> <p style="text-align: left;"><strong><em>ultra</em></strong><em>focused – Work together to fearlessly uncover new possibilities</em></p> <p style="text-align: left;"><span class="TextRun SCXW119083716 BCX8" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW119083716 BCX8">Ultragenyx is seeking an experienced and highly motivated </span><span class="NormalTextRun SCXW119083716 BCX8">Associate</span><span class="NormalTextRun SCXW119083716 BCX8"> Director, Regulatory Affairs (Clinical/Nonclinical Strategy), </span><span class="NormalTextRun SCXW119083716 BCX8">EMEA </span><span class="NormalTextRun SCXW119083716 BCX8">who is a team </span><span class="NormalTextRun SCXW119083716 BCX8">play</span><span class="NormalTextRun SCXW119083716 BCX8">er and enjoys a fast paced, dynamic work environment.  The </span><span class="NormalTextRun SCXW119083716 BCX8">Associate</span><span class="NormalTextRun SCXW119083716 BCX8"> Director will be </span><span class="NormalTextRun SCXW119083716 BCX8">responsible for developing key </span><span class="NormalTextRun SCXW119083716 BCX8">EMEA </span><span class="NormalTextRun SCXW119083716 BCX8">regulatory strategies and executing submissions while monitoring and assessing </span><span class="NormalTextRun SCXW119083716 BCX8">EMEA </span><span class="NormalTextRun SCXW119083716 BCX8">regulations including G</span><span class="NormalTextRun SCXW119083716 BCX8">ene </span><span class="NormalTextRun SCXW119083716 BCX8">T</span><span class="NormalTextRun SCXW119083716 BCX8">herapy</span><span class="NormalTextRun SCXW119083716 BCX8"> guidance and regulation changes.</span><span class="NormalTextRun SCXW119083716 BCX8"> </span><span class="NormalTextRun SCXW119083716 BCX8">This position will report to the </span><span class="NormalTextRun SCXW119083716 BCX8">Senior Director Regulatory Affairs EMEA</span><span class="NormalTextRun SCXW119083716 BCX8">.</span></span><span class="EOP Selected SCXW119083716 BCX8" data-ccp-props="{"134233279":true,"201341983":0,"335559740":256}"> </span></p> <h3 style="text-align: left;"><strong>Work Model: </strong></h3> <p style="text-align: left;">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.</p> <h3 style="text-align: left;"><strong>Responsibilities:</strong></h3> <ol> <li style="line-height: 2;"><span data-contrast="auto">Interfaces with EMEA regulatory agencies as appropriate on select programs.</span><span data-ccp-props="{"134233117":true,"201341983":0,"335557856":16777215,"335559739":60,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Independently research options for regulatory strategies and presents recommendations at regulatory sub teams and to leadership.</span><span data-ccp-props="{"134233117":true,"201341983":0,"335557856":16777215,"335559739":60,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">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.</span><span data-ccp-props="{"134233117":true,"201341983":0,"335557856":16777215,"335559739":60,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Provide regulatory guidance for the EMEA region and input throughout product development to the regulatory sub team.</span><span data-ccp-props="{"134233117":true,"201341983":0,"335557856":16777215,"335559739":60,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Lead cross functional teams in EMEA Regulatory Filings (e.g. CTAs, GMOs, MAAs)</span><span data-ccp-props="{"134233117":true,"201341983":0,"335557856":16777215,"335559739":60,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Lead selects Regulatory vendor meetings in alignment with product programs and Regulatory-driven projects</span><span data-ccp-props="{"134233117":true,"201341983":0,"335557856":16777215,"335559739":60,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Maintain CTAs ensuring Agency compliance</span><span data-ccp-props="{"134233117":true,"201341983":0,"335557856":16777215,"335559739":60,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Review clinical documentation, including protocols, DSUR’s, Investigator Brochures, Investigator Packages and General Investigational Plans to ensure GCP and Agency compliance</span><span data-ccp-props="{"134233117":true,"201341983":0,"335557856":16777215,"335559739":60,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Lead teams in the development of briefing documents for EMEA Agency meetings</span><span data-ccp-props="{"134233117":true,"201341983":0,"335557856":16777215,"335559739":60,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Manage and direct contractors/vendors as needed on programs</span><span data-ccp-props="{"134233117":true,"201341983":0,"335557856":16777215,"335559739":60,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Keep current with EMEA Agency guidelines and regulations</span><span data-ccp-props="{"134233117":true,"201341983":0,"335557856":16777215,"335559739":60,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Prepare comments on draft documentation sent out for consultation from the health authority</span><span data-ccp-props="{"134233117":true,"201341983":0,"335557856":16777215,"335559739":60,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Contribute to creation of local labels as needed</span><span data-ccp-props="{"134233117":true,"201341983":0,"335557856":16777215,"335559739":60,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Coordinate submission schedule with Publishing, ensuring delivery of high-quality documents</span><span data-ccp-props="{"134233117":true,"201341983":0,"335557856":16777215,"335559739":60,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Participate on cross-functional committees and sub-teams in accordance with company initiatives, as necessary</span><span data-ccp-props="{"134233117":true,"201341983":0,"335557856":16777215,"335559739":60,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Provides supervision and mentoring to junior regulatory professionals on the team, if applicable</span><span data-ccp-props="{"134233117":true,"201341983":0,"335557856":16777215,"335559739":60,"335559740":240}"> </span></li> </ol> <h3 style="text-align: left;"><strong>Requirements:</strong></h3> <ol> <li style="line-height: 2;"><span data-contrast="auto">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</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Strong knowledge and experience in interpretation of EMEA regulations and guidelines related to drug development</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">In depth understanding and application of industry standards and international regulations and guidelines.</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Experience in communicating regulatory strategy, submission documents and plans both internally and externally</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">The desire and ability to work in a fast-paced, start-up environment</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Strong collaboration, teamwork, organizational skills at attention to detail</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Requires initiative, creative problem-solving ability and excellent verbal and written communication skills</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li> </ol> <p><strong><span style="color: #ffffff;"><span class="ui-provider wf b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak" style="color: #000000;"><span style="color: #ffffff;">#LI-CK1</span> <span style="color: rgb(255, 255, 255);">#LI-Hybrid</span></span></span></strong></p><div class="content-conclusion"><div> </div> <div><strong><em>Full Time employees across the globe enjoy a range of benefits, including, but not limited to:</em></strong></div> <div> </div> <div><strong><em>·         Generous vacation time and public holidays observed by the company</em></strong></div> <div><strong><em>·         Volunteer days</em></strong></div> <div><strong><em>·         Long term incentive and Employee stock purchase plans or equivalent offerings</em></strong></div> <div><strong><em>·         Employee wellbeing benefits</em></strong></div> <div><strong><em>·         Fitness reimbursement</em></strong></div> <div><strong><em>·         Tuition sponsoring</em></strong></div> <div><strong><em>·         Professional development plans</em></strong></div> <div> </div> <div><em>* Benefits vary by region and country</em></div> <div> <p><strong>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 </strong><a href="mailto:talentacquisition@ultragenyx.com"><strong>talentacquisition@ultragenyx.com</strong></a><strong>.</strong></p> </div> <div><em>See our </em><a class="postings-link" href="https://www.ultragenyx.com/CCPA-Notice/"><em>CCPA Employee and Applicant Privacy Notice</em></a><em>.</em></div> <div><em>See our </em><a class="postings-link" href="https://www.ultragenyx.com/privacy-policy/">Privacy Policy</a><em>.</em></div> <div> <p><strong>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.</strong></p> </div> <div><strong>Note to External Recruiters</strong>: 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<em>: </em><a class="postings-link" href="http://mailto:talentacquisition@ultragenyx.com/">talentacquisition@ultragenyx.com</a><em>.</em></div></div>